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How to cite this article Mendes RCCG, Ribas A, Macedo IP, Buschle M, Ataide AL, Pereira R, Kochen AP, et al.
Several studies have shown that cochlear implants may reduce or even eliminate tinnitus in patients with bilateral profound hearing loss.
Keywords: cochlear implants, deafness, language and hearing sciences, speech, speech perception, tinnitus. Tinnitus means perceiving a sound that is not being generated in the environment at that time. Considered one of the most common symptoms of profound sensorineural hearing loss, tinnitus can significantly affect the quality of life of individuals2. The latest international publications7,8 suggest that patients with unilateral hearing loss, or even severe hearing loss, presenting ipsilateral tinnitus with hearing loss, unresponsive to several treatments, may also benefit from electrical stimulation of the auditory nerve through the CI. The beneficial effect of a CI on tinnitus can be explained by acoustic masking, by electrical stimulation directly to the auditory nerve, and especially by the reorganization of the central auditory system and associative brain areas that occurs after activation of the implant. The aim of this study was to describe the audiological results of a patient with asymmetric hearing loss with ipsilateral disabling tinnitus, who was underwent the CI procedure. Throughout the ENT care, various treatments were performed without success, for the reduction or remission of tinnitus, which led the patient at the time to have suicidal thoughts.
The patient underwent cochlear implant surgery to the right ear in an attempt to improve auditory acuity, but mainly as a last resort in tinnitus treatment.
Before the CI, results were compatible with profound hearing loss to the right ear and severe loss to the left. After the CI, thresholds compatible with normal hearing on the right ear were observed, as shown in Figure 1.
We used the Glendonald Auditory Screening Procedure (GASP test)12 which classifies the category of hearing on a scale of zero to six, where zero means no detection of speech sounds and six means open-set speech recognition.
The protocol for assessing tinnitus was applied at the following times: before surgery, 45 days after surgery (activation of CI), two months later, six months later and one year after CI surgery. The literature11 states that the CI is configured as an alternative treatment of deafness and constitutes a multifactorial process with proven effectiveness. The Brazilian study17 indicates that the hearing assessment obtained six months after the first implant programming demonstrates that English-speaking patients get excellent results in tests of recognizing words and sentences in open presentation, regaining useful hearing. Despite these satisfactory and known findings by physicians and audiologists, the primary complaint by the subject, which is the focus of this study, was the tinnitus. Di Nardo et al.6 reported that the CI provides effective results in reducing the perception of tinnitus intensity.
Statistically significant reduction in THI overall indices and sub-indices, pre and post CI, were demonstrated in scientific studies8,11 showing lower levels of discomfort and a decrease in the intensity of tinnitus as a result of direct electrical stimulation of the auditory nerve and reorganization of the central auditory pathways and cortical association areas, leading to the use of tinnitus as a criterion for choosing the ear to be implanted. The results related to the concentration (66%), emotional (100%), sleep (26%) and hearing (96%) obtained by preoperative TAQ converged at a rate of 72% indicating strong interference of tinnitus, especially in the emotional and hearing states of the patient. Factor 3, life prospects, went from a preoperative score of 100% to 50% after activation of the CI, 25% after two months of use, 75% after six months and reduction to 25% after 1 year of CI use. The consulted study11 shows that the CI generates maximum benefit in remission buzz around seven months after the performed procedure. The reduction in the intensity and degree of tinnitus annoyance confirms the improvement in the quality of life of individuals, a fact that must be considered in preoperative counseling of patients with tinnitus as candidates for cochlear implants.
CI as a treatment for post-lingual profound hearing loss is highly effective, there is improvement seen in hearing thresholds in performance and perception of speech sounds, as in the case presented.
Although the literature describes the indication of CI for patients with tinnitus, the initiative is still not being widely accepted by physicians and speech-language pathologists, especially when hearing loss is unilateral or asymmetric. Paper submitted to the ITJ-SGP (Publishing Management System) on May 21, 2013; and accepted on June 21, 2013. How to cite this article Der C, Alzerreca E, Martin JTS, Roman L, Zamorano I, Malhue J, Aliaga P, et al.
INTRODUCTION: The psycho-emotional assessment is of utmost importance for evaluation of patients with tinnitus. OBJECTIVES: We propose a linguistic validation of the THI, in order to obtain reliable answers in our country. MATERIALS AND METHODS: We performed a translation of the original English questionnaire and assessed its feasibility by applying it in a group of patients with tinnitus.
CONCLUSIONS: The adapted version of the THI shows satisfactory levels of internal consistency for the assessment of disability caused by tinnitus.
Its intensity is variable, from almost imperceptible to intolerable and intrusive, significantly compromising patient's quality of life (QOL) and even leading to suicidal ideation4. The clinical characterization of tinnitus allows defining groups which try to orientate different etiologies and helps to establish conduct.
For the measurement of the psychological impact and the disability of tinnitus, the test known as Tinnitus Handicap Inventory (THI, Newman & Jacobson, 1967). This test consists of 25 questions easily understood by the patients with three answers for every question: "yes", "sometimes", or "not". The THI is subdivided in three subscales, first, Functional scale, named by Newman consisted of 11 items, including the area of mental function (for example. The second subscale is the Emotional scale composed by 9 items that include affective answers provoked by the tinnitus, as anger, frustration, irritability and depression (for Example. The THI is translated into several languages and adapted or validated according to the language and the idiosyncrasy of every country in numerous publications. We realized a prospective study and analysis for statistical validation of a quality test of life and its psychological impact. Finally we realized a Pearson's coefficient of correlation between the result of the total score of THI-CL and each of his subscales by the age of the patient and we used the statistical program JMP 9 Version. With regard to the answers of each one of 25 items in the questionnaire THI-CL, the percentage of answers "yes" changed between a range of 4-70%; for the response "sometimes" this percentage changed between 5-45 % and for the response "not", this variation was between 20-84 % (Table 2). The great individual variability for the degree of interference in the daily life and the disability that the tinnitus provokes, determines an imperious need to use questionnaires that value the impact produced by this one. Of alternative or complementary form, multiple instruments of measurement have been in use, as the visual analogous scale (VAS) who, in response to a precise question, codes in a scale from 0 to 10 the magnitude of a criterion as the intensity of perception of the tinnitus or the level of induced inconvenience17. From the publication of the THI, numerous translations and validations to different languages have arisen as response to the need of make an objective evaluation in these patients of the level of psychological affectation that they show.
One of the characteristics that do the THI one of the most worldwide applied questionnaires in the patients' evaluation with tinnitus is his easy accomplishment correction and interpretation, demonstrating in different international studies a great facility of reproduction for the evaluation of tinnitus after a treatment14,15.
The easy reproduction and reliability in the evaluation of the psychological impact of the tinnitus, has done of the THI an important questionnaire in the patients' study with tinnitus submitted to a therapeutic intervention. The application of the THI questionnaire has spread to other areas of the audiology, as the evaluation of the adjustment to auditory prostheses in patients with hypoacusia and tinnitus, where it is possible to quantify the degree of satisfaction and response of the patient to his treatment21.
The adapted version of the THI to our population presents a suitable equivalence with the original version in English, with satisfactory levels of internal consistency and easy reproduction, so that it is possible to use it in the Chilean population for the evaluation of the disability generated by tinnitus.
This validation supposes an important help on having generated a tool to know the impact of this symptom in the quality of life of our patients, and providing criteria to measure the evolutionary control of the therapeutic interventions. Institution: Surgery Department, ENT Unit, Clinica Alemana de Santiago, Facultad de Medicina Clinica Alemana, Universidad del Desarrollo, Santiago, Chile.
Paper submitted to the ITJ-SGP (Publishing Management System) on July 12, 2013; and accepted on August 12, 2013.
Current theories of tinnitus assume that the phantom sound is generated either through increased spontaneous activity of neurons in the auditory brain, or through pathological temporal firing patterns of the spontaneous neuronal discharge, or a combination of both factors.
To measure the efficacy of CRA® neuromodulation, we devised a powered, two-center, randomized controlled trial (RCT) compliant with the reporting standards defined in the Consolidated Standards of Reporting Trials (CONSORT) Statement. This RCT was designed to provide a confident high-level estimate of the efficacy of sound therapy using CRA® neuromodulation compared to a well-matched placebo intervention, and uniquely in terms of sound therapy, examine the physiological effects of the intervention against its putative mechanism of action.
BackgroundThe phantom auditory sensation of tinnitus is transiently experienced by most people, but for 10 to 15% of the population, and up to one in three of older adults, the experience is chronic [1, 2]. Permission to conduct the study was granted by the National Research Ethics Service (NRES) Committee, East Midlands a€“ Nottingham 1, Nottingham, UK, and the trial sponsor is the Nottingham University Hospitals National Health Service (NHS) Trust, Research and Innovation department, Nottingham, UK.Population and sample sizeParticipants will be recruited through leaflets placed in audiology, and ear, nose and throat (ENT) departments, and any direct contacts made to the recruiting centers in response to publicity in the national media. Pure-tone audiometry will be conducted in a soundproof booth using the Unity 2 system (Siemens, Berlin, Germany) and HDA 200 headphones (Sennheiser, Wedemark, Germany), measuring hearing thresholds between 125 and 12,000 Hz.Participants will be withdrawn from the trial at any point if they commence any other form of tinnitus therapy, or if following commencement of the study they report an adverse event. Placebo controlParticipants in the placebo group will also receive the same device and be presented with a sequence of tones. Participants will be reassessed at planned intervals over the 36 weeks of the trial (Figure 1), or at an interim interval if they experience a noticeable change in tinnitus pitch. DiscussionVarious forms of sound and sound enrichment are in use for the clinical management of tinnitus. AcknowledgementsDJH and DAH are funded by the National Institute for Health Research (NIHR) Biomedical Research Unit Program.
Competing interestsDJH, DM and DAH were awarded industry grants from The Tinnitus Clinic (Brook Henderson Group, Reading, UK), and Adaptive Neuromodulation GmbH (ANM), KA¶ln, Germany) to conduct this trial. We will be provided with an authorization token (please note: passwords are not shared with us) and will sync your accounts for you. Objective: To describe the quantitative treatment outcomes of patients undergoing acoustic coordinated reset (CR) neuromodulation at a single independent audiology practice over a 22- to 26-week period as part of an open label, non-randomized, non-controlled observational study.
Conclusion: Acoustic CR neuromodulation therapy appears to be a practical and promising treatment for subjective tonal tinnitus.
Tinnitus is the involuntary perception of sound, in the absence of corresponding auditory stimuli, which is perceived as originating within an individual’s ears or head. There is a strong evolving body of evidence that suggests that subjective tinnitus perception is linked to some form of peripheral audiological insult. However, it is important to note that there is a growing amount of evidence that implies that the actually salient conscious perception of tinnitus requires the involvement of a significant network of brain areas (14, 15). There is currently no European Medicines Agency (EMA) or Food and Drug Administration (FDA) approved pharmacotherapies available for the treatment of subjective tinnitus. Acoustic coordinated reset (CR) neuromodulation is a non-invasive desynchronizing stimulation therapy that aims at counteracting pathological neural synchrony in subjects with subjective tonal tinnitus (6, 19). This article reports the experience of a cohort of adult patients suffering from chronic subjective tonal tinnitus when treated with acoustic CR Neuromodulation over a 22- to 26-week period within an independent audiology clinic setting. A total of 66, fee paying, participants (44 male and 22 female) ranging in age from 31 to 76 years (with a mean of 57 years and a SD of 13 years) completed 22–26 weeks of therapy.
The level of patient tinnitus severity was measured prior to the initiation of therapy using the tinnitus handicap inventory (THI) (26). Visual analog scale for perceived tinnitus loudness and annoyance were utilized as the primary outcome measurement. The tinnitus handicap questionnaire (THQ) (28) was used as the secondary outcome measurement. The subject’s characteristic tinnitus frequency was assessed using a manufacturer designed pure tone matching protocol, where the intensity and frequency of the matching tone were controlled by an audiologist and the patient. Patients were then stimulated for a 22- to 26-week treatment period using a portable acoustic device (T30 CR neurostimulator) coming with ear phones adapted from receiver-in-the-ear-canal (RIC) hearing aids that ensured that the subject’s auditory meatus was not occluded by the headphone receiver.
The temporal, spatial, and frequency characteristics of the generated tones were determined via the CR algorithm [Ref. Patients were seen at four subsequent follow up appointments, post fitting, in order to have the characteristic pitch of their tinnitus rematched. Descriptive statistics was used for each of the four variables (THQ, VAS loudness, VAS annoyance, and tinnitus pitch) and the three time points. The recording of VAS scores at follow up appointments, compared to baseline, revealed a significant reduction for both tinnitus loudness and annoyance. Sixty-four of the patients surveyed experienced a change in their pitch matched percept frequency, at 12 and 24 weeks, which required the neurostimulator system to be retuned to the newly perceived frequency. A small number of subjects within this investigation recorded a THI score of 16 points or less, which is described as being only audible in quiet environments and having no impact upon sleeping or daily activities (32).
The primary objective of this article is to report whether tinnitus sufferers could experience a reduction in tinnitus symptoms from acoustic CR neuromodulation therapy when it is delivered in an outpatient setting. It is interesting that while patients with slight THI category scores did not report a clinically significant score change with respect to the THQ the psychoacoustic parameters of percept loudness and annoyance did decrease in a much more significant way.
Acoustic CR neuromodulation was well tolerated with all patients reporting, at the 24-week follow up consultation, of being able to commit to the required daily usage routine. This investigation would also benefit from being repeated as a clinical trial with the addition of a control group of patients who receive counseling and appropriate amplification as this would provide a direct comparison intervention with which to gage the intervention under scrutiny. However, there are not consistent references regarding ipsilateral tinnitus compared to unilateral profound hearing loss. It is a very frequent symptom, which may affect around 17% of the population in some countries. Several studies claim that the cochlear implant (CI) can diminish or even eliminate the perception of tinnitus in patients with bilateral profound hearing loss and that, although a risk of tinnitus perception that increases after implantation exists, it is very small3-6.
With the support of these findings researchers suggest that tinnitus should be a selection criterion in choosing which ear to implant and that patients with severe unilateral hearing loss associated with severe tinnitus can be considered CI candidates9-11. The comparison between the responses obtained before and after the CI verify the benefits achieved with this therapy. The tests were conducted in a soundproof booth, with the Madsen Itera - GN Otometrics audiometer. The test was applied prior to the CI, five months later, eight months later, and finally, after a year. This fact was borne out in this case report, where the pre and postsurgical audiometric tests showed improvement in tone thresholds with CI use. In this study, by applying the VAS, we observed a significant reduction in the intensity of tinnitus perception, and that after activation of the CI, the rating went from four to one after 60 days of using the device. In our study, after activation of the CI, there was a reduction in the THI total index (six) and sub-indices (functional 2, catastrophic 0, and emotional 4) to a score of one. A total reduction of assessed scores on aspects of sleep and concentration with a reduction of greater than 20%, significant data regarding the emotional and hearing aspects, was observed after activation of the CI. In our study there was a significant reduction in the percentage of THQ (Table 3) after activation of the CI and the subsequent evaluations (two and six months of CI use) mainly in factors 1 and 2. In addition, it can be seen that the CI was critical to the reduction of tinnitus perception.
Speech, Language and Hearing Sciences - Universidade Tuiuti do Parana - Curitiba - PR - Brasil. Department of Otolaryngology - Hospital Infantil Pequeno Principe - Curitiba - PR - Brasil.
Speech, Language and Hearing Sciences - Hospital Infantil Pequeno Principe - Curitiba - PR - Brasil. The Tinnitus Handicap Inventory (THI), is the most known and validated test for this purpose.


Statistical analysis included internal validity (Cronbach's alpha) and linear correlation tests (Pearson coefficient). It is a frequent reason for consultation and patients come to a wide range of professionals: otolaryngologists, neurologists, psychiatrists, psychologists, and others.
Other reasons include exposition to noises, traumas of head and neck, local inflammation and use of medicaments10. In the first case, it will allow to measure the magnitude of the symptom, to know the effect of therapies, or to follow-up patients. Firstly tinnitometry, which involves the confrontation of frequency and intensity, the mask ability of tinnitus and the search for the residual inhibition and secondly and most important, psycho-emotional medicine12. Has been accepted by the principal centers because of its reliability, safety and supported validity13,14. It gives 4 points to "yes", 2 points to "sometimes", and 0 point to "not", and the sum of the total score goes from 0 to 10013,14. For Spanish-speaking population exists a Spanish version of Herraiz et al.15, translated from the English and adapted to the daily language of Spain. As specific aims we will try (1) to generate a test of auto application and easy correction in the clinical national services, (2) to obtain a reliable method for the measurement of results in the treatment of tinnitus in Chilean patients, (3) and to rely on an instrument that it should allow to measure the degree of psychological impact and disability generated by tinnitus.
Translation of the original document in English "Tinnitus Handicap Inventory" of Newman and cols.
Viability of the questionnaire: in the second phase, a group of ENT residents, of Spanish native language evaluated the questionnaire. Application of the questionnaire: a group of 60 patients with tinnitus was submitted to the questionnaire THI-CL in his final version, for evaluation of disability produced by the tinnitus.
Statistical Analysis: We calculated the frequency of distribution, medians and standard diversion of every item of the questionnaire THI-CL.
For it, the acufenometrics measurements do not contribute sufficient information to establish a category or degree of psycho-emotional severity that allows to certify the condition of a patient in a certain minute of his disease or treatment.
Other authors have published experiences with questionnaires as the Beck's scale of depression, of frequent use in psychology, to estimate in an objective way the disability produced for tinnitus18. As is demonstrated in the original version and in the Danish and Italian validation, Chilean version of the THI does not seem to be affected by age and sex so much for the total score and for each of his sub scales, which contributes furthermore to his cultural validity19,20.
Our experience was similar, achieving that the patients were answering entirely the questionnaire in all the cases, without difficult reports before the exposition of a question. Is considered to be significant, a difference bigger than 20 points between the initial pre-treatment questionnaire and the result post therapy in the follow-up14.
With this in mind, Tass and colleagues recently tested a number of temporally patterned acoustic stimulation strategies in a proof of concept study. The RCT design also addresses the recent call for international standards within the tinnitus community for high-quality clinical trials.
Although factors contributing to tinnitus potentially include otologic, neurologic, infectious, and drug-related effects, it is most readily associated with noise exposure and aging [3a€“5].
Center 1 is the National Institute for Health Research (NIHR) Nottingham Hearing Biomedical Research Unit, Nottingham, UK. Written informed consent will be obtained from each participant in accordance with the permissions granted. The placebo tones will include frequencies in the 500 to 4,000 Hz range, but excluding frequencies around the tinnitus pitch.
The device prescription will be reassessed at each visit, and when there is a change in tinnitus pitch it will be adjusted accordingly.
Typically sound is used to either mask tinnitus (introduce enough sound energy to cover up the percept of tinnitus and provide a temporary relief), partially mask tinnitus (reduce the percept so that the patient can adjust or a€?habituatea€™ to the sound), or to promote relaxation or distract attention away from the tinnitus sound [31].
RHP and HT are employed on this funding.Authorsa€™ contributionsDJH, DM and DAH developed the protocol. This means that you will not need to remember your user name and password in the future and you will be able to login with the account you choose to sync, with the click of a button. This page doesn't support Internet Explorer 6, 7 and 8.Please upgrade your browser or activate Google Chrome Frame to improve your experience. Patients had their tinnitus severity recorded prior to the initiation of therapy using the tinnitus handicap inventory in order to categorize patients into slight up to catastrophic impact categories. However, due to the lack of a control group it is difficult to reach an absolute conclusion regarding to what extent the observed effects are related directly to the acoustic CR neuromodulation therapy. This phenomenon can affect all age groups (1), but is more likely to affect individuals who are over the age of 60 (2).
Even subjects who have normal audiometric thresholds have been shown to have outer hair cell damage (3) and dead cochlea regions (4). MEG has been used to investigate long-range cortical networks of individuals with tinnitus and demonstrated that information flow from the global network to the temporal cortex correlated positively with the strength of tinnitus distress (16). The CR algorithm has been developed computationally and is designed to desynchronize neural networks by reducing the strength of synaptic connectivity between neurones within the cell population (6, 20, 21). Twenty-one subjects were pre-existing hearing aid users who reported that their prescriptions improved their quality of life, 28 subjects did not have a sufficient loss to warrant the use of amplification, and 17 subjects had tried hearing aids in the past 4 years but did not report that they had benefited from their prescriptions. VAS loudness and VAS annoyance tinnitus metrics have demonstrated a significant convergent validity with the TQ and test–retest reliability has determined the minimum identifiable clinical difference (MICD) to be 10 points for a 100 point VAS scale (22, 27). Prior to completing VAS and THQ, patients were required to cease active stimulation for a minimum of 15 min.
This method was found to be very time consuming with the approximate unilateral pitch matching time being of 45 min in duration. A readjustment of the stimulation parameters could occur at these visits if the matched tinnitus frequency had changed. Of the seven patients who recorded a THQ at 24 weeks no beneficial clinical effect was revealed with scores remaining remarkably static at both outcome appointments (mean change at 24 weeks was 5.9%). This may be explained by tinnitus having a very low-emotional impact on subjects in this group making the THQ metric very resistant to change even if tinnitus loudness and annoyance were decreased by the therapy. This would also serve to determine what degree of improvements may have occurred as a result of a placebo effect. However, considering that the majority of patients were shown to experience a progressive improvement in symptoms in contrast to the effect of previous structured interventions serves to make placebo induced effects improbable. The aim of this paper is to describe audiological results of a patient with asymmetrical hearing loss with incapacitating ipsilateral tinnitus in the ear subjected to cochlear implant surgery.
We do not know its prevalence in Brazil, but if we extrapolate the data from our international population, it is possible that some 28 million Brazilians have already had some form of tinnitus1. Chart 1 shows the comparison between the results where it can be verified that the patient progressed from category zero to six in the 12-month study. The patient went from category zero to six, where there is open-set recognition of words and phrases together. The degree of discomfort, intolerance or failure often are not related to the intensity of tinnitus, says a consulted study1, but mood disorders (depression, dysthymia) and anxiety often present, exerting strong influences on the worsening of the tinnitus. After 180 days of use, the patient did not perceive any ringing with the CI turned on and noticed only mild tinnitus with the CI off. Influence of evoked compound action potential on speech perception in cochlear implant users. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Stimulation by cochlear implant in unilaterally deaf rats reverses the decrease of inhibitory transmission in the inferior colliculus. Techniques for assessing auditory speech perception and lipreading enhancement in young deaf children. Resultados auditivos com o implante coclear multicanal em pacientes submetidos a cirurgia no Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo.
In the UK up to 5% of the adult population is at least moderately annoying by tinnitus and in 1% severely affects its QOL2,5.
The subjective tinnitus cannot be perceived by another person, whereas the other can be identified by the examiner by means of auscultation or another method8. This score determines degrees of disability for tinnitus from slightly to severely impaired (Table 1). Due to the tinnitus, is it difficult to enjoy social activities as going out to eat or going to the cinema?), and the area of physical function (for Example. The third scale is the Catastrophic scale composed by 5 items that reflect the desperation of the patient, disability to be able to escape of the problem, perception of having a critical illness, loss of the control and his disability to face the problem (for Example. This version differs from our language in vocabulary and does not correspond to the linguistic local culture, without exist up to the minute experiences published of his use in Chile. After possessing authorization of the author for the accomplishment of the project, we made a translation of the original questionnaire to the Spanish in independent form, for doctors of bilingual and Spanish native language.
In a group activity, every article was read while the participants were following the reading in a printed material.
For the analysis of internal consistency of the test or reliability, we applied the test of Cronbach's Alpha Coefficient to the total score of the THI-CL questionnaire and every subscale.
These measurements allow to quantify of a reproducible form, although subjective, the severity and the tolerance of a tinnitus. In the article of Newman, the authors justify the low value obtained by the limited number of questions that compose this scale (5 items). One of the limitations of the questionnaire happens when the initial score is minor to 20 points, situation in which statistically there has not corroborated a difference between both measurements14. Bases fisiopatologicas del tratamiento del tinnitus neurosensorial: Rol del sistema auditivo eferente. Psychometric adequacy of the Tinnitus Handicap Inventory (THI) for evaluating treatment outcome. Evaluacion de la incapacidad provocada por el tinnitus: homologacion linguistica nacional del Tinnitus Handicap Inventory (THI). Correlation analysis of the visual-analogue scale and the Tinnitus Handicap Inventory in tinnitus patients. Brazilian Portuguese Language version of the "Tinnitus Handicap Inventory": validity and reproducibility.
Potential therapeutic sound regimes were derived according to a paradigm assumed to disrupt hypersynchronous neuronal activity, and promote plasticity mechanisms that stabilize a state of asynchronous spontaneous activity. The design uses a between-subjects comparison with minimized allocation of participants to treatment and placebo groups.
Among the most frequently reported difficulties associated with tinnitus are sleep disturbance, hearing difficulties, social withdrawal, and negative emotional reactions, such as anxiety and depression [6a€“10].
The primary outcome measure of treatment efficacy is the Tinnitus Handicap Questionnaire (THQ) [17], where the maximum score is 2,700.
The placebo tones will also be delivered at a slower repetition rate and are predicted not to have the same therapeutic effect as the treatment stimulus. When a participanta€™s tinnitus pitch is increased beyond the output limits of the device, that is, tinnitus at or above 10.5 kHz, the participant will pause using the device for 2 weeks, and will then be reassessed.
Such approaches clearly target the psychological component of tinnitus (the negative emotional reaction), but are not clearly linked to any putative physiological mechanism of tinnitus generation. Also, as the observed patient group was made up of paying clients it is unknown as to whether this could have caused any additional placebo like effects to influence the final results.
This peripheral damage is thought to result in central neural plastic changes that affect the balance between excitatory and inhibitory processes leading to a potential promotion of increased afferent activity (5) and neural synchronicity (6).
This provides evidence for the concept that percept salience is linked to an altered functional interaction between auditory and non-auditory brain areas. Treatments that are commonly utilized in order to improve quality of life include patient counseling (regarding etiology and prognosis), hearing aids, sound therapy, and cognitive behavioral therapy (17). In order to desynchronize a synchronized focus in the tonotopically organized auditory cortex, four acoustic tones are delivered with different frequencies centered on the characteristic frequency of the participant’s tinnitus percept (19). Pure tone audiometry revealed subjects to have sensorineural hearing losses, which ranged from mild to moderate – severe (Figure 1A).
This formula reflects the non-linear tonotopic organization of the auditory cortex and utilizes the matched frequency of each participant’s tinnitus percept. The effect size was also calculated for all outcome measures using the mean and SD of the scores.
VAS scores were recorded from the same individuals plus one additional patient at 24 weeks.
A similar reduction of tinnitus loudness and distress has been shown in a randomized proof-of-concept trial (19), an outpatient study (TRI conference 2011, Buffalo, NY, USA, Abstract H. We think that this relatively short observation period after stimulation offset is not long enough to name these effects long-term effects, but clear sustained effects were observable.
An extended test period to 52 weeks or beyond would provide more information on the sustainability of the intervention therapeutic effect.
A spontaneous resolution of symptom is also improbable due to the sustainable nature of the tinnitus percept in the majority patients surveyed as part of this investigation. The results of the patient population that are reported in this manuscript were obtain from patients treated at a London based clinic owned by The Tinnitus Clinic Ltd. Audiological exams and responses to perception protocols for tinnitus before and after surgery were analyzed. Without a personal sound amplification device (PSAP) during the application of the GASP, the patient reported that he felt only a slight vibration in the right ear to the presented sound stimuli. In our study, the patient reported he had considered suicide due to the discomfort caused by tinnitus. Experiencia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo. Likewise, we can distinguish the pulsatile tinnitus and the not-pulsatile; the first one is usually vascular, especially in unilateral tinnitus concordant with the patients' pulsations6.
In 2006, Pena et al.16 proposed a linguistic homologation of this scale publishing a translation to the Spanish local language.
On the basis of these translations a questionnaire was made in Spanish who was checked and retro translated into the English for a professional certified translator. They should have answered to 2 questions for every article: what does deal you with this question?
It was considered to be a criterion of incorporation, 18 year-old patients, with tinnitus subjectively diagnosed, unilateral or bilateral of more than 6 months of duration and refractory to treatment. Besides, calculation of the Cronbach's alpha coefficient was realized eliminating an item to the time of the questionnaire simultaneously, for determine the dependent variation of each item.
In our experience, a satisfactory result was obtained, without difference between the sub scales.


With regard to this limitation, Newman et al.14, postulate that only the change of category of disability degree (Table 1), would allow to demonstrate an improvement later to the establishment of a treatment. A minimization approach was selected to ensure that the two groups are balanced with respect to age, gender, hearing, and baseline tinnitus severity. Intrusive tinnitus is, therefore, a complex condition that arises with different etiologies and comorbidities.
Participants meeting the inclusion criteria will be randomized to either the intervention group (Group 1) or the placebo group (Group 2) of a 12-week RCT. THQ data from a published study of tinnitus maskers were used to estimate the required sample size (two-sample t-test power analysis, performed in R). After 12 weeks, participants in the placebo group will crossover to start receiving the treatment according to the intervention algorithm, and will follow the same protocol as initially delivered to Group 1.The RCT phase of this study will be conducted double-blind.
The placebo does, however, represent an active intervention, since the participant may experience some level of tinnitus masking while the device is worn.Device fitting procedureThe tinnitus assessment and the device programming procedure will be identical for all participants.
Acoustic CRA® neuromodulation, however, explicitly targets a physiological marker of tinnitus, that of pathological synchronous oscillatory activity in the brain [32a€“35], measurable using EEG.To generate high-level evidence for the efficacy of CRA® neuromodulation, the RCT described here was designed to meet the reporting standards defined in the Consolidated Standards of Reporting Trials (CONSORT) Statement [36].
It is interesting to note that tinnitus generation is unlikely to be the result of an abnormally enhanced or hyperactive nerve firing pattern originating from the peripheral auditory system as sectioning of the auditory nerve does not, typically, eliminate tinnitus in pre-existing cases (7). There is also data from studies that show auditory cortical γ band activity to be strongly increased, for noise exposed subjects, within the very early stages of tinnitus onset (13).
However, with the possible exception of cognitive behavioral therapy, there is a lack of sufficiently large randomized control trials to demonstrate the efficacy of other commonly used interventions (18). This reduction in neural synchrony is considered to cause a decrease in the connectivity across brain areas involved in the larger salience network (15, 22). There were a total of eight patients who recorded a 0–16 point score with respect to their pre treatment THI, which is a category that has been suggested, by the THI questionnaire authors, to potentially be below the threshold of clinical significance.
THQ data from a published study of tinnitus maskers were used to estimate MICD for the metric (31) found that a difference in mean THQ score of 194 was considered significant, and represented a medium effect size. Acoustic CR neuromodulation employs the use of an equal number of tones that are generated above and below the subject’s specific tinnitus frequency.
Wurzer) and in a real life study in 200 patients suffering from chronic tonal tinnitus (25). Christian Hauptmann is employed by Juelich Research Center; formerly working with ANM GmbH (Cologne, Germany). The tests showed improvements in the hearing threshold on the side with the implant, improvements in speech perception and a significant reduction in tinnitus perception, which consequently led to an improvement in the patient's quality of life.
Shortly after activation of the CI he began to recognize open-set word and auditory performance, improving at each evaluation. In children has been described in 6.5% of patients, although up to 34% refers tinnitus when directly questioning7.
Finally the coherence was compared between the version retro translated to English and the original version in English to obtain a definitive questionnaire. Was considered a criterion of exclusion the presence of neurological disease or have psico-organic damage. The proof of concept study, conducted in Germany, confirmed the safety of the acoustic stimuli for use in tinnitus, and exploratory results indicated modulation of tinnitus-related pathological synchronous activity with potential therapeutic benefit.
The protocol ensures double blinding, with crossover of the placebo group to receive the proprietary intervention after 12 weeks. Management of tinnitus typically involves relieving the distress, anxiety or depression that can accompany tinnitus, masking the sound by introducing external sound, or reducing the neural signal believed to be causing the tinnitus.Current theories of tinnitus assume that the phantom sound is generated either through increased spontaneous activity of neurons in the auditory brain, or through pathological synchrony of the spontaneous neuronal discharge, or a combination of both factors (see Roberts et al. After 12 weeks, the placebo group will be unblinded and continue on the study according to the treatment protocol. Participants will not know the group to which they are allocated (intervention or placebo).
The individuala€™s dominant tinnitus pitch is determined using an adaptive bracketing method.
At the time of writing the protocol for the funding application, this questionnaire was one of the better validated measures of tinnitus severity, responsive to treatment-related change, and with a test-retest reliability of 0.93 [24].
The RCT design also addresses the recent call for an international standard within the tinnitus community [37] in the form of a powered, blinded RCT with a mix of meaningful and validated outcome measures, to best capture clinical significance and change in tinnitus percept and related physiology. It has also been noted that cochlea pathology causes a reduction in spontaneous firing rates in mammalian auditory nerve fibers (8).
Although it is still unclear if this elevation in γ band activity is influenced by noise-induced hearing loss. A randomized proof-of-concept trial has provided evidence for acoustic CR neuromodulation to be an effective therapy for tinnitus by demonstrating a significant improvement in visual analog scale (VAS) scores and tinnitus questionnaire (TQ) outcome measures scores for 75% of patients (19). All participants presented with tinnitus as their primary complaint with the length of time since tinnitus onset ranging from 3 months to 27 years (with a mean of 7 years and an SD of 8 years). These low category patients did, however, report of the tinnitus percept to be sufficiently bothersome to warrant their engagement in structured therapy and determined to proceed with the intervention at their discretion. The stimulation tones are matched for loudness and presented at approximately 10–15 dBSPL above threshold. The reduction of tinnitus loudness and annoyance VAS scores, within this investigation, correlated with previous work relating to tinnitus measurement variables (33). However, the tinnitus suppression effects reduce after 4 weeks post cessation of treatment, which indicates that a continuous treatment period extending beyond 12 weeks is appropriate in order to achieve a maximal therapeutic effect. He works as consultant for Brook Henderson Group and has received research funding from the European Community, the Federal Ministry of Education and Research (Germany), the Deutsche Forschungsgemeinschaft, the Helmholtz Association. These three axes: pulsatility, laterality and if it is objective or subjective can make a diagnostic approximation and orientate the clinician to a certain etiology.
The answers were taken in account by a group reviser composed by medical specialists in otolaryngology for final alterations to the questionnaire. We didn't realize segregation on the basis of audiometric results or demographic variables.
Additional to this, we realized a Student's t-test for independent samples, to define if the total score of the THI-CL and each of his sub scales were presenting statistically significant differences between men and women.
The most effective stimulation paradigm is now in clinical use as a sound therapy device, the acoustic coordinated reset (CRA®) neuromodulation (Adaptive Neuromodulation GmbH (ANM), KA¶ln, Germany). The primary endpoints are the pre- and post-treatment measures that provide the primary measures of efficacy, namely a validated and sensitive questionnaire measure of the functional impact of tinnitus.
After the RCT, all participants will be followed for a further 24 weeks in a long-term extension (LTE) arm (Figure 1).
The researcher assessing outcomes will not know which group the participant was allocated to. These observations serve to implicate activity changes in central structures as being the causal factor for the phantom percept generation.
Forty-two of the subjects had received tinnitus therapy previously via audiologists and psychologists in both independent and socialized healthcare clinics. The presentation cycle consists of four tones played in a randomized order over three stimulation cycles followed by a pause in stimulation that lasts the equivalent time period of two presentation cycles. No correlation, for treatment effect, was determined with respect to patient age, gender, and audiometric configuration. The same study also reported that TQ scores progressively improved for subjects who participated in an additional 24 weeks of therapy once the blinded trial had been completed. The Nitesh Patel declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. In this manner we finished the confection of the questionnaire THI in his national version in Spanish. There was delivered an informed consent to every patient who should have been well-read and signed before the participation in the study and possess the approval of the Scientific Educational Department and Committee of Ethics of German Clinic of Santiago for the development of the investigation.
The trial is also designed to capture secondary changes in tinnitus handicap, quality (pitch, loudness, bandwidth), and changes in tinnitus-related pathological synchronous brain activity using electroencephalography (EEG).
Theoretical modeling studies indicate that such aberrant activity patterns might be reduced through acoustic stimulation [12, 13]. The primary endpoints are the pre- and post-intervention metrics that provide the primary measures of efficacy, that is, responses about thoughts and feelings associated with tinnitus measured using a validated questionnaire. If we therefore assume a difference in mean THQ score of 250 between groups with a pooled SD of 425 as representative of a large effect size, then for a two-sided significance level of 0.05 and 80% power, it is estimated that 47 participants are required for each group. The audiologists fitting and adjusting the device will be blind to group allocation since they will be unaware whether the device programming code supplied to them after the participant is randomized generates an intervention or placebo stimulus. Once this bracket has been established, a two-alternate forced-choice method is used to determine a dominant tinnitus pitch. Cortical map reorganization has previously been suggested as being a central correlate for the emergence of tinnitus (9).
It is also interesting to note that a significant number of trial participants also experienced a reduction in the characteristic frequency of their tinnitus over the course of the study (19). The specific type of therapy utilized in these centers was diverse in nature and included diverse counseling methods, hearing aid prescriptions, tinnitus retraining therapy, sound therapies, and cognitive behavioral therapy. These results support our findings that in an outpatient setting a treatment for 36 weeks is most probably favorable as compared to a 12 weeks treatment. While Schaette and Kempter [12] proposed that sound enrichment provided by prolonged use of a hearing aid could counteract neuronal hyperactivity and reduce tinnitus, Tass and Popovych [13] proposed using sound to interrupt pathological connectivity and synchronous firing that may underlie tinnitus in a process termed a€?coordinated reseta€™ (CRA®).
Repeated measures of general quality of life, tinnitus handicap (as measured by two other tinnitus questionnaires), resting state EEG, and psychoacoustic measure of tinnitus percept will also be collected as secondary outcome measures. Once a dominant pitch is reliably identified, the proprietary software uses an algorithm to program a set of four stimulation tones that span above and below the tinnitus pitch. This 25-item questionnaire was very recently developed as a sensitive measure of treatment-related change in tinnitus distress with a clinically significant change defined at 13 points. However, MEG data demonstrating altered spectral power, in subjects experiencing tinnitus, suggest that this does not adequately explain the emergence of the percept in a satisfactory manner (4). The results obtained in the randomized proof-of-concept trial (19) were confirmed in a real life study in 200 patients suffering from chronic tonal tinnitus (25). Treatment was provided at charge, and this could have biased findings in some unpredictable fashion.
CRA® was first modeled computationally by Tass [14] as a method using high-frequency pulse trains to desynchronize the concerted activity of neural subpopulations.
The device will be fitted by an appropriately trained audiologist using a custom sound console to determine a pitch matching the participanta€™s tinnitus percept, and to calculate a unique sequence of tones around that pitch to be employed in the treatment protocol for each individual. Tones are then loudness matched, such that the participant subjectively equates each tone to be at a soft but audible listening level. The THQ was used as an outcome measure and although this questionnaire was developed and validated with great rigor and is used widely [see Ref.
The tones are presented by the device at a level that is only slightly higher than the hearing threshold for those tones, that is, a comfortable quiet level that should not interrupt the participanta€™s normal daily routine. All tones are compared against each other to ensure equal loudness.All participants are prescribed with bilateral stimulation.
Participants will be instructed to wear the device for 4 to 6 hours daily during the RCT stage.
Participants with unilateral tinnitus (experienced in one ear) will be prescribed bilateral stimulation with the same prescription. For loudness matching, participants adjust the level of 11 sound clips (center frequencies 500 to 12,000 Hz) until each one is perceived to equal that of the tinnitus sound.
Given that the model of CRA® was not specific to electrical stimuli, Tass and Popovych [13] also modeled the potential CRA® effects of acoustic stimulation on tinnitus-related brain activity, concluding it to hold promise as a tinnitus treatment.
During the LTE stage, participants in the intervention group will be advised to wear the device for at least 4 hours daily. Participants with bilateral tinnitus that differs in pitch between ears by more than 200 Hz will require different stimulation prescriptions for each ear.
A sensation level is then calculated according to the matched value at a single frequency where there is little or no hearing loss and the frequency is distant from the dominant tinnitus pitch. All participants who do not perceive tinnitus to be in the ear will be prescribed bilateral stimulation with the same prescription (Figure 3). Next, a tinnitus spectrum representing bandwidth is generated by asking participants to rate the likeness of the same 11 sounds to the pitch of their tinnitus, using a 100-point scale. Bandwidth can then be calculated as the SD of all frequencies in the tinnitus spectrum, where each frequency is weighted by its percentage likeness to the tinnitus pitch identified by the participant (compare [28]).
A dominant tinnitus pitch is taken as the frequency in the spectrum with the highest likeness rating.EEG spontaneous oscillatory activityTo assess changes in spontaneous oscillatory activity, EEG will be performed using a Neuroscan system (SynAmps2 model 8050, Compumedics Neuroscan, Charlotte, NC, USA) with 66 equidistant scalp electrodes. The most effective stimulus paradigm is now in clinical use as a sound therapy device, the acoustic CRA® neuromodulation (Adaptive Neuromodulation GmbH (ANM), KA¶ln, Germany).
EEG will be conducted at baseline and at the end of the 12-week RCT for the first 50 participants (25 intervention, 25 placebo) attending Center 1 in Nottingham. At the 12-week visit, EEG will be performed after behavioral assessment, at a minimum 2-hour break from stimulation. For the recording, participants will be seated in a quiet, darkened soundproof booth, have their eyes open and be instructed to fix their gaze on a marker point in front of them. A central frontal electrode will be used as ground and a nose-tip electrode as reference, and two additional electrodes will be placed below the eyes to monitor eye movements. Any missing data will be imputed using an expectation-maximization method, which assumes a normal distribution for the partially missing data and bases inferences on the likelihood under that distribution (maximum 25 iterations, performed in SPSS v16.0, IBM, Armonk, USA).
Effect sizes will be calculated with Cohena€™s d computed with the pooled SD of the two groups.Following completion of the trial, the sponsor will use all reasonable endeavors to ensure the appropriate publication of the research. However, the investigators have the right to publish results of the statistical analysis, conducted according to the protocol, whether they are positive or negative, and whether they support or negate the commercial interests of the manufacturer.Baseline characteristics of participants will be reported as descriptive statistics, including but not limited to age, gender, hearing levels, anxiety, depression, medication, tinnitus duration, tinnitus severity, tinnitus dominant pitch, and tinnitus loudness estimates. Comparisons between groups will assess the degree to which comparability of randomization was achieved.Efficacy analysesOur primary endpoint and first analysis of data will be the end of the 12-week RCT.
Pre-processed data (high- and low-pass filtering, offline epoching, artifact correction) will be further corrected for artifacts using independent component analysis (ICA) in EEGLAB [30].
Power analysis will be carried out in the EEGLAB, and obtained power spectra will be divided to analyze oscillatory activity in normalized EEG frequency bands. Non-parametric statistical tests will be used to test for significant differences in any change in oscillatory activity between the placebo and intervention group. Within-group comparisons of activity recorded pre- and post-intervention will also be performed.Safety analysisAdverse events that occur during the trial will be recorded and reported according to the trial sponsora€™s standard operating procedure (SOP) for medical device trials (Nottingham University Hospitals NHS Trust SOP 52).



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