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19.11.2014
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Background: Repetitive transcranial magnetic stimulation (rTMS) has been studied as a treatment option for chronic tinnitus for almost 10 years now.
Subjective tinnitus is defined as a perception of sound that is not linked to an internal or external sound source. Studies using positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) indicate altered neuronal activity in the central auditory system in patients with chronic tinnitus (for a review see Lanting et al., 2009).
Some previous studies which examined the effect of rTMS on chronic tinnitus already reported an influence of clinical characteristics on treatment outcome.
Demographical and clinical characteristics were assessed by using the Tinnitus Sample Case History Questionnaire (Langguth et al., 2007a).
Assessment of treatment effects was performed using standardized procedures as established in the TRI database (Landgrebe et al., 2010).
Patients were treated with rTMS on 10 consecutive working days, receiving one of two possible treatment protocols. In a first step, correlations between the dependent variables and all predictors were conducted. Only some of the predictors were significantly correlated with treatment outcome and these correlations were, though statistically significant, only weak to moderate ones (see Table 2). In the group receiving combined treatment more investigated variables had a significant effect on treatment outcome. The current results from a large sample indicate that rTMS significantly decreases tinnitus severity in tinnitus patients. Regarding the stimulation protocol, both temporal and combined stimulation resulted in a decrease of tinnitus severity on day 12, but significant improvement on day 90 was only observable in the patients receiving combined stimulation. Regarding predictors for treatment outcome, some of the characteristics analyzed were significantly correlated with treatment outcome. In detail, the changing TQ score from screening to baseline is the strongest predictor for treatment outcome, reaching statistical significance for both treatment groups and both day 12 and day 90. Although tinnitus is a common international problem, often clinicians find they are unsure of how to treat their tinnitus patients. Second, in the absence of widespread training in treatment approaches for severe debilitating tinnitus in the 1990s, TRT filled a void in the clinical armamentarium of the audiology community. Individuals meeting the eligibility criteria have an equal probability of being randomized to one of the three treatment groups in the TRTT. The standard-of-care treatment is similar to that typically provided to patients with severe tinnitus at the participating military medical centers.
Additional secondary outcomes include change in the Digit Symbol Substitution Task [77] and the EuroQol. 56.Schmitt C, Kroner-Herwig B, Comparison of tinnitus coping training and TRT: Are they superior to education? The newest Treatment for Tinnitus is Neuromonics, and we are proud to offer this innovative, music-based therapy at our clinic beginning in October 2006. The PINK SOUND PROTOCOL consists of a 16 week Cognitive Behavioral Guide that will take you effortlessly through four months of solid directive education and counseling exercises, specifically complied from Dr. Long-Term Results from Tinnitus Retraining Therapy article from the American Academy of Audiology. 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. 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. Although most of these studies have demonstrated beneficial effects, treatment results show high interindividual variability and yet, little is known about predictors for treatment response. It is considered a common symptom affecting about 10–15% of adults (Hoffman and Reed, 2004) some of which are considerably impaired in their everyday lives. These alterations supposedly result from reorganization processes in the central nervous system that occurs as a consequence of abnormal auditory input (Eggermont, 2005).
This follows the consensus for patient assessment and outcome measurement approved by tinnitus experts from many countries during an international tinnitus conference in 2006 (Langguth et al., 2007a). Dependent on levels of measurement, product-moment correlations, point biserial correlations, or eta were used. In both groups, TQ difference from screening to baseline and treatment outcome on both day 12 and day 90 were negatively correlated. Only variables significantly correlated with treatment outcome were included in the analyses. Owing to the large sample size, the rather small change in TQ scores (between 4–10%) reaches statistical significance while the effect sizes are only small to moderate.
These correlations have to be interpreted with caution however, as they are only weak to moderate ones.
This robust finding is remarkable since the time interval between screening and baseline was not standardized and varied across patients. Enabling JavaScript in your browser will allow you to experience all the features of our site. The Patient Counseling Guide is designed to be used one-on-one with tinnitus (and hyperacusis) patients, designed as a double-sided resource with information for the clinician on one side and patient information on the other. The tinnitus management is based on the patient's complaints, history, audiologic evaluation, and self-assessment. Acceptance and commitment therapy versus tinnitus retraining therapy in the treatment of tinnitus: A randomised controlled trial.
Celebrating a decade of evaluation and treatment: The University of Maryland Tinnitus and Hyperacusis Center. Tinnitus Retraining Therapy (TRT) as a method for treatment of tinnitus and hyperacusis patients.
The functional neuroanatomy of tinnitus: Evidence for limbic system links and neural plasticity. Adaptive plasticity of loudness induced by chronic attenuation and enhancement of the acoustic background. Hyperacusis and related sound tolerance complaints: Differential diagnosis, treatment effects, and models.
Shifts in dynamic range for hyperacusis patients receiving Tinnitus Retraining Therapy (TRT).
Incremental shifts in loudness discomfort level among tinnitus patients with and without hyperacusis.
Changes in loudness discomfort level and sensitivity to environmental sound with habituation based therapy. Modification of loudness discomfort level: Evidence for adaptive chronic auditory gain and its clinical relevance. Evaluation of tinnitus retraining therapy in comparison to cognitive therapy and broad-band noise generator therapy.
Outcomes of long-term outpatient tinnitus-coping therapy: Psychometric changes and value of tinnitus-control instruments. A critical analysis of directive counselling as a component of tinnitus retraining therapy.
Marsha Johnson, Doctor of Audiology, practices state-of-the-art treatment for these troublesome conditions. Our successful clinic program offers the latest and newest treatment for tinnitus and hyperacusis and is one of only a small handful of full time tinnitus & hyperacusis clinics in the world.
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. Chronic tinnitus is often accompanied by hearing loss, comorbid depression, sleeping problems, anxiety, and psychological stress (Halford and Anderson, 1991; Langguth, 2011).
Furthermore, altered activity has also been found in non-auditory areas such as the frontal cortex or the amygdalohippocampal area (for a review see Adjamian et al., 2009). As not every variable was available for every patient, the table provides sample sizes for each variable separately. As both protocols differ substantially with respect to stimulation sites and number of stimuli, data from the 1 Hz and 20 + 1 Hz treatment were analyzed separately. This means that those patients in which the TQ score increased from screening to baseline benefited more from treatment with rTMS than patients with improvement from screening to baseline. Of course, the question arises if this small decrease in tinnitus severity can be considered not only statistically significant but also clinically relevant.
Two parameters were significantly correlated to treatment outcome in both treatment groups: the change of tinnitus severity from screening to baseline and the tinnitus severity at baseline.
Patients worsening from screening to baseline benefited more from rTMS than patients who had improved between screening and the beginning of rTMS treatment. Anyone who is interested in providing tinnitus management with TRT will find this book immensely useful, practical, and resourceful.
The goal of the treatment is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well being and quality of life.
Additionally, we are evaluating the impact of change in tinnitus severity on outcomes related to the participant's health by assessing change from baseline in the Hearing Handicap Inventory, [79] Beck Depression Inventory Fast Screen, [80] Positive And Negative Affect Schedule, [81] and state sub-scale of the State-Trait Anxiety Inventory. 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.
Tinnitus sufferers are considered a heterogeneous group of patients which might be divisible into several subgroups with different underlying pathophysiologies and thus benefiting from different treatment options (Landgrebe et al., 2010).
As repetitive transcranial magnetic stimulation (rTMS) is able to modify cortical excitability, it has been introduced as a new treatment option for chronic tinnitus. For calculation of the hearing level [dB HL], all thresholds measured in pure-tone audiogram from 125 Hz to 8 kHz and from both sides were averaged. For both protocols, stimulation intensity was set at 110% of the individual resting motor threshold but never higher than 60% of maximal stimulator output. In a second step, those predictors showing significant correlations with the independent variables were analyzed in a multiple regression analysis. Both groups showed similar responder rates which were stable over time: among the patients receiving temporal stimulation, 37% improved by five points or more on the TQ score at day 12 and 36% at day 90. Furthermore, in both treatment groups, the TQ score on baseline was negatively correlated with treatment outcome on day 12 and day 90.
In all analyses, the TQ difference from screening to baseline proved to be a significant predictor for treatment outcome. Furthermore, in the group receiving combined stimulation, patients with comorbid temporomandibular complaints benefited more from rTMS than patients without temporomandibular complaints. Tinnitus may be heard continuously or intermittently within one or both ears or within the head. Specific treatment recommendations are individualized to reflect the participant's concerns and coping abilities as well as his or her engagement in the decision-making process regarding treatment options.The double-blind sound therapy, implemented with a placebo-controlled sound-generator device, is an innovative feature of the TRTT. Controlled prospective study of tinnitus retraining therapy compared to tinnitus coping therapy and broad-band noise generator therapy.
Pawel Jastreboff, Director of the University of Maryland Tinnitus & Hyperacusis Clinic.
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). Numerous demographic, clinical, and audiological variables as well as different tinnitus characteristics were analyzed as potential predictors for treatment outcome, which was defined as change in the tinnitus questionnaire (TQ) score. In addition to these diverging results, most of the mentioned studies investigated only small samples and examined only the influence of demographical data, tinnitus side, and tinnitus duration on treatment outcome.
Motor threshold was defined as the minimal intensity sufficient to produce motor-evoked potentials of at least 50 μV in the left thenar muscle in five out of 10 trials. In the group treated with temporal plus frontal stimulation, 38% of patients were classified as responders at day 12 and 38% at day 90.
Accordingly, patients with higher TQ scores at baseline had more pronounced TQ reductions after rTMS than patients with low TQ baseline scores.
Finally, a significant influence of comorbid temporomandibular complaints on treatment outcome was found. For the group receiving temporal stimulation, TQ score at baseline appeared as an additional predictor for treatment outcome on day 90 but did not reach statistical significance in the remaining analyses (see Table 3). Additionally, depressivity at baseline (assessed by the BDI score) was significantly correlated with treatment outcome on day 12 in patients receiving temporal stimulation. Other earlier rTMS studies did not analyze whether changes of tinnitus severity before treatment start has an influence on treatment effects. Neither the study participant nor the treating audiologist will know the type of sound generator that the study participant receives. 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. However, it still remains a major challenge to identify useful criteria for identifying clinically relevant subtypes.
These magnetic fields are produced by a pulsed electrical current flowing through a coil which is placed on the scalp. Tinnitus pitch was defined as the geometric mean of the lower and upper bound frequency [Hz] measured during the audiological examination. A similar result appeared for the BDI score on baseline: the higher the score on baseline, the more decrease in tinnitus severity was observed. Patients suffering from temporomandibular complaints experienced more benefit from rTMS than patients without temporomandibular complaints.
BDI score on baseline, which was only included in one regression model (temporal stimulation, day 12), was detected as a significant predictor in this model. Although the mean TQ score reduction and the effect size of rTMS are small, it brings improvement to patients who would otherwise have no real therapeutic alternatives. In the group receiving combined stimulation, patients with constant tinnitus showed more improvement on day 12 compared to patients with intermittent tinnitus. Several explanations can be provided for this relative robust finding of an influence of the pre-treatment changes on treatment effects.
Tinnitus may or may not be associated with a known causal event or suspected pathology.Estimates broadly place the prevalence of tinnitus between 10% and 20%, corresponding to ~30-60 million affected persons in the US population. This neuroimaging evidence, in turn, has provided support for the concept of directive counseling and its importance in the TRT protocol in initiating habituation of the inordinate emotional and negative responses to the tinnitus. Because it is not possible to blind study participants, nor the treating audiologist, to directive counseling versus the standard of care, all audiological outcomes will be measured by a second audiologist who is blinded to the treatment assignment.
Immediately before treatment assignment, each study participant completes the tinnitus health-related quality-of-life instruments and other psychological profile tests. 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.


The magnetic fields pass through the skull and induce an electrical current in the underlying cortical neurons.
The aim of the current study is, therefore, to identify predictors for treatment outcome, including a larger amount of clinical and demographic variables as potential predictors. All participants were treated at the Tinnitus Center at the University of Regensburg, Germany and gave written informed consent after comprehensive explanation of the procedures. However, this latter result is only true for treatment outcome on day 12 and only in the group receiving temporal stimulation.
Furthermore, in the group receiving combined stimulation, temporomandibular complaints predicted treatment outcome on both day 12 and day 90, whereas tinnitus manifestation (intermittent vs. The small effect sizes should, therefore, not lead to the conclusion that rTMS is not efficient enough to be examined in future studies.
However, those latter results were not found for treatment outcome on day 90 indicating that neither depressivity nor tinnitus manifestation exert considerable influence on long-term effects of rTMS. The change between screening and baseline may reflect anticipation effects which are known from waiting list control groups (Hesser et al., 2011a). Roughly 5% of the affected population seek healthcare for their tinnitus (~15 million persons). There is an inherent risk of information bias in the TRTT in that the tinnitus health-related quality-of-life outcomes are being completed by the study participant.The TRTT is being conducted at US military medical centers with active-duty and retired military personnel and their dependents, all of whom qualify because of their severely distressing tinnitus. The initial treatment visit takes place following the randomization visit, and is followed by a second treatment visit 1 month later. 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.
In the group receiving combined treatment, patients with comorbid temporomandibular complaints benefited more from rTMS than patients without those complaints.
If applied repetitively, long lasting changes in the excitability of directly stimulated cortical neurons as well as in functionally connected areas can be obtained. In order to identify the possible existence of different predictors for treatment with temporal and for combined frontal plus temporal rTMS, both treatment protocols were examined separately. Patient data was kept confidential throughout all analyses, which have been approved by the local ethics committee. For all patients, a Medtronic system with a figure-of-eight coil (90 mm outer diameter; Alpine Biomed, Minneapolis, MN, USA) was used with the handle of the coil pointing upwards.
The small effect sizes rather point to the potential of rTMS, but also to the need for future studies to further improve treatment outcome by applying rTMS over new stimulation sites or by changing stimulation frequencies (Kleinjung and Langguth, 2009a). This assumption is supported by regression analysis which reveals that only two of the parameters mentioned remain as significant predictors of treatment outcome: change of tinnitus severity from screening to baseline and suffering from temporomandibular disorder (for patients receiving combined treatment only). For example, one of the ideas motivating sound therapy is that exposure to an enriched sound environment is critical in regulating a compensatory process, operating within the central auditory pathways, to amplify otherwise undetectable tinnitus activity. Although the incidence and prevalence of tinnitus among US military personnel is unknown, it is probably much higher than that among the overall population because of increased exposure to loud noise.
Follow-up visits at clinical centers take place at 3, 6, 12, and 18 months, and include completion of tinnitus outcome questionnaires at all visits.
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. In addition, patients with higher TQ scores at baseline had more pronounced TQ reductions than patients with low TQ baseline scores. It depends on stimulation parameters if those changes act in an inhibitory or excitatory way (Ridding and Rothwell, 2007).
The analysis has been conducted on pooled data stored in the database of the tinnitus research initiative (TRI) (Landgrebe et al., 2010), providing large sample sizes and thus allowing generalization of results. Patients with a history of epilepsy, cardiac pacemakers or other contraindications to TMS were excluded from treatment. Screening data were collected when patients visited the Tinnitus Center for the first time (generally during tinnitus consultation hours), whereas baseline data were collected immediately before treatment started. 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. Also, patients who had already improved from screening to baseline benefited less than patients without initial improvement. To test for changes in tinnitus severity from baseline to day 12 as well as from baseline to day 90, paired t-tests were used. In the interim, a more detailed description of the TRTT study design and its development will be forthcoming in a separate report.
Conclusions: The results from this large sample demonstrate that rTMS shows only small but clinically significant effects in the treatment of chronic tinnitus.
The six military clinical centers now participating in the TRTT include three Navy and two Air Force sites and the newly integrated-service site at the Walter Reed National Military Medical Center. To identify predictors for treatment outcome, all variables listed in Table 1 were included as potential predictors.
Participation in and completion of a TRT training course has effectively served the tinnitus clinical and patient community as qualification to conduct TRT. The participating Navy sites are the Naval Medical Center Portsmouth, the Naval Hospital Camp Pendleton, and the Naval Medical Center San Diego. Besides demographical data and hearing loss, several tinnitus characteristics and selected somatic disorders like headache or neck pain were analyzed. These ongoing training efforts, together with numerous presentations at professional and scientific meetings by Jastreboff, Hazell, and independent clinicians using TRT, propelled TRT to the forefront of treatment for debilitating tinnitus at the turn of this century. The participating Air Force sites are the David Grant Medical Center at Travis Air Force Base and the Wilford Hall Ambulatory Surgical Center at Lackland Air Force Base. It would, therefore, be of high clinical relevance to find out, which patient characteristics are predictive for treatment outcome as it would then be possible to offer rTMS more systematically to those patients who will most likely show positive response. Differences of TQ scores between baseline and day 12 as well as between baseline and day 90 were used as variables for treatment outcome. US Army clinical centers are also expected to join the TRTT as new treatment sites over the next year to enhance and expedite study recruitment. The authors thank the US Navy and Air Force for their continued support of this project, acknowledge the significant contributions of General Hearing Instruments, Inc. As the baseline score was used as subtrahend, negative values describe an improvement in tinnitus severity whereas positive values describe a worsening of tinnitus. For the vast majority of tinnitus patients, the tinnitus signal is believed to arise in the cochlea or auditory periphery (source), and is filtered out at a subcortical level as shown in [Figure 1]. In the foreword for a special issue of the Journal of the American Academy of Audiology devoted to tinnitus, Jacobson stated that "TRT has become the non-medical management of this decade" for treating severe tinnitus. The main feature of the TRTT study population is that patients have severely debilitating subjective tinnitus with onset of symptoms at least 1 year prior to treatment. More detailed knowledge about clinical and demographic characteristics of treatment responders may also shed light on the neurobiological mechanisms of rTMS in the treatment of tinnitus. Although tinnitus may be detectable, it is not bothersome in this conceptual representation of the model.
This manuscript is based on a presentation at the 5 th International Tinnitus Research Initiative Conference held in Grand Island, NY in August 2011. Accordingly, the majority of Americans who experience tinnitus at one time or another are neither routinely aware nor annoyed by their tinnitus. This research has been approved by the Institutional Review Boards at all participating military clinical sites, the University of Alabama, and Johns Hopkins University. However, in severely debilitated patients, estimated at 1-2% of the US population, conscious and subconscious neuronal circuitry is activated by the distress accompanying the tinnitus. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Departments of the Navy and Air Force, Department of Defense, or the United States Government.This work was prepared as part of official duties performed by the military service members and civilian employees participating in the TRTT project. Many of these reports appeared at the Sixth and Seventh International Tinnitus Seminars in 1999 and 2002, respectively.
This engagement includes activation of the subcortical, associated cortical areas, and auditory cortex, as well as the limbic and autonomic nervous system structures depicted in the model. A review of some of these early reports and other relevant studies [Table 2] revealed clinical success rates approaching or exceeding 80% (as judged by a minimum of 20% change on two or more tinnitus-specific, health-related, quality-of-life scales) across various study populations.
If at the conclusion of treatment TRT is ultimately successful in habituating the negative reactions (H R ), emotional associations (H E ), and tinnitus perception (H P ), as shown in [Figure 3], then the model for the successfully treated, previously distressed tinnitus patient will be the same as that shown in [Figure 1]. 101 defines a United States Government work as a work prepared by a military service member or employee of the United States Government as part of that person's official duties. They also argued that "a randomized trial with some agreeable controls" is unnecessary because "the validity of this study, time frame, and sample of patients will be questionable and will face many ethical issues" (p. Other components of the model are not activated and, therefore, there is neither awareness nor annoyance in response to the tinnitus. This depiction of the model is representative of the vast majority of persons with tinnitus, who are neither bothered nor distressed by their tinnitus (After Jastreboff[21])Click here to viewFigure 2: Neurophysiological model of tinnitus depicting full activation, including activation of non-auditory limbic and autonomic nervous system structures that are responsible for the emotional and negative reactions to the tinnitus. This engagement of both conscious and subconscious neuronal circuitry gives rise to the awareness and annoyance associated with distressing tinnitus (After Jastreboff[21])Click here to viewFigure 3: Neurophysiological model of tinnitus depicting complete tinnitus retraining therapy - induced habituation of the emotional (HE) and negative (HR) reactions to the tinnitus and it perception (HP). The most valid objection to TRT continues to be the lack of scientific evidence from rigorously controlled randomized trials to support the efficacy of TRT, its component parts (directive counseling and sound therapy), or the underlying mechanisms. A Wessex Institute report pointed out multiple methodological shortcomings in the early observational studies of TRT. Sound therapy reinforces the habituation process and facilitates the habituation of the perception (awareness) of the tinnitus through enrichment of the tinnitus patient's sound environment.
Exposure to low-level background noise from sound therapy makes tinnitus more difficult to resolve, while also resetting central auditory gain processes that are thought to play a critical role in tinnitus. Habituation of the tinnitus perception, which follows after habituation of the negative reaction, ostensibly occurs automatically. Sound therapy may be achieved by any reasonable means that enriches the patient's sound environment, including the use of personalized bilateral ear-worn sound generators and hearing aids.
TRT, however, yielded a superior outcome for patients with greater tinnitus severity at the start of treatment. Bauer and Brozoski [65] reported that both TRT and general counseling, without additional sound therapy, are efficacious in reducing the annoyance and impact of tinnitus. The TRT-related improvements accrued over an 18-month period and were reported to be robust and clinically significant.
Westin et al.[1] compared the treatment effects of acceptance and commitment therapy (ACT) with TRT for reducing the impact of tinnitus.
They reported that ACT yielded significantly greater reductions in tinnitus impact than did TRT at 10 weeks, 6 months, and 18 months after onset of the assigned treatment. The results from a third trial, led by Richard Tyler at the University of Iowa, are yet to be published.
Specifically, it was noted in the Cochrane review of TRT to be a primary factor, eliminating many TRT-related studies from review consideration. In some cases, the counseling has been expanded to include aspects or features of cognitive behavioral therapy, which may have influenced or confounded previous reports of TRT efficacy.
Moreover, no published randomized study to date has controlled for the treatment effects of directive counseling or sound therapy apart from their combined effects in TRT, nor have investigators examined the relative contributions of these components to TRT success in a rigorous trial. Thus, in the persistent absence of a rigorous and definitive randomized controlled trial, we proposed and were funded by the National Institute of Deafness and Other Communication Disorders (NIDCD), National Institutes of Health, to conduct the first large-scale, randomized, placebo-controlled, multi-site clinical trial of TRT, the Tinnitus Retraining Therapy Trial (TRTT), which is described in the remainder of this report. The primary objective of the TRTT is to assess the efficacy of TRT as a treatment for severe debilitating tinnitus. The TRTT includes persons with functionally adequate hearing sensitivity who do not need to use hearing aids.



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