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Severe disabling tinnitus (SDT) refers to a symptom severe enough to disrupt affected patients' routine and keep them from performing their daily activities.
In 2000, using single-photon emission computed tomography (SPECT) and the benzodiazepine radioligand 123I lomazenil, Shulman et al. In a 2002 retrospective study, Gananca [7] found that clonazepam was very effective and safe in the treatment of SDT. Generally accepted today is that SDT of cochlear origin always has a central component that keeps the symptom active, even after deafferentation [9]. We used the VAS to measure the degrees of intensity and annoyance before and after the drug treatment. After 6 weeks of treatment, the degrees of intensity and annoyance of tinnitus were again measured via the VAS.
SDT intensity and annoyance were significantly decreased in groups 1 and 3 as compared to group 1, but no statistically significant difference was detected between groups 2 and 3 (Tables 4-12).
Four patients in group 2 experienced drowsiness and nausea, and two patients had sexual dysfunction (clonazepam). Tables 7-12 show the statistical analyses of the results using the SSPS version 13 software (SPSS Inc.), and Figure 1 summarizes the results in the three groups.
The discrepancy between Shulman's results and ours may be due to the different patient populations but, to be sure about that, it is necessary to study patients with SDT of a predominantly central origin, comparing the results of placebo, benzodiazepines alone, and benzodiazepines combined with GABAergic drugs.
The addition of GABAergic drugs to benzodiazepines does not modify the results of the treatment of SDT of predominantly cochlear origin. This study was performed with help from Fundacao de Empreendimentos Cientificos e Tecnologicos (FINATEC), Brasilia-DF, Brazil. Presented at the Twenty-Fifth Meeting of the Politzer Society, Seoul, Korea, October 5-9, 2005. How to cite this article Daftary A, Shulman A, Strashun AM, Gottschalk C, Zoghbi SS, Seibyl JP.
Tinnitus affects nearly 50 million people in the United States, with a minority demonstrating marked functional impairment. Tinnitus is defined as a sensory disorder of auditory perception reflecting an aberrant auditory signal produced by interference in the excitatory-inhibitory processes involved in neurotransmission [1]. Although some have speculated regarding the pathophysiological mechanisms associated with severe centraltype tinnitus, little is definitively understood.
123I-iomazenil is a partial inverse agonist of the benzodiazepine receptor (BZR) and has been used in a number of studies evaluating the role of gamma aminobutyric acid (GABA) mechanisms in neuropsychiatry disorders [6-10]. The study was performed in accordance with the protocols approved by the institutional review board at the Yale University School of Medicine. Three venous blood samples were collected at 240, 300, and 360 minutes (means ± SD: 264 ± 25 minutes, 324 ± 2 1 minutes, and 369 ± 1 5 minutes, respectively) after starting the infusion of iomazenil, and blood samples were analyzed as previously described [14]. The primary imaging outcome measures of this study were (1) the homotypic ratio of count density for the a priori selected brain regions, (2) the regional equilibrium distribution volume determined by the ratio of activity in brain region divided by the concentration of parent compound, and (3) statistical parametric analysis of tinnitus patients compared with age-and gendermatched controls. This study was an intrasubject analysis in which assessment of the asymmetry in distribution of BZR in homotypic brain regions was performed. The concentration of the free fraction of iomazenil in plasma was calculated at three different time points as described (except in one patient, owing to technical reasons).
As regards asymmetry of radiotracer distribution in homotypic brain regions, V3' data from the regions already described were analyzed using a Wilcoxon signed rank test. Statistical analysis of volume-of-interest activity in homotypic regions showed statistically significant asymmetry in BZR density (expressed as V3' ) in the superior temporal cortical region. Comparison of cases and controls showed a significant decrease in counts in the frontal lobes (p = .000) and an insignificant decrease in the cerebellum. This study evaluated patients with severe intractable tinnitus using a bolus and constant infusion of 123I-iomazenil SPECT brain imaging.
In the first part, we analyzed asymmetry in V3' values in each region of interest (volume of interest), findings that would enable us to identify visually detectable difference, which may assist in interpretation of these scans in the future and act as a direct measure of receptor distribution. The results of the voxel-based SPM analysis also suggest changes in BZR distribution in the frontal lobes and, to a lesser extent, in the cerebellum. Conclusions based on these data should be tempered by several issues in the study design; these include a relatively small number of patients studied, potential confound of age on BZR in the healthy control population, and effect of drug treatment on the imaging. Multiple studies show that short-term administration of benzodiazepines produces mild to no change that reverses rapidly on cessation of therapy [6,27].
Some studies have shown alteration in cerebral metabolism with the presence and absence of symptoms [21]. Finally, imaging measures of alteration in the density of BZR binding may well represent an epiphenomenon associated with tinnitus rather than the primary pathophysiological process.
This preliminary study of BZR distribution in a cohort experiencing severe, chronic tinnitus supports temporal, frontal lobe, and cerebellar involvement in the disorder.
This work was generously supported by the Martha Entenmann Tinnitus Research Center, Inc., Brooklyn, NY. Zeng (in photo at top of page), a bioengineer and director of the Hearing and Speech Lab at UC Irvine. Benzodiazepines and GABAergics in Treating Severe Disabling Tinnitus of Predominantly Cochlear Origin. SDT of a predominantly central origin has been treated successfully with benzodiazepines and GABAergic drugs. This prompted us to test the treatment with benzodiazepines and GABAergic drugs in SDT of predominantly cochlear origin following a prospective, randomized, singleblind protocol. We defined them as patients who had a 7 or higher score in a visual analog scale (VAS) ranging from 1 (negligible intensity and annoyance) to 10 (unbearable intensity and annoyance).
The patients were randomly assigned to three groups: group 1 was treated with placebo, group 2 with clonazepam, and group 3 with clonazepam and GABAergic drugs. Five patients in group 3 reported drowsiness and nausea, and two noticed interference with cognition (clonazepam and gabapentin).
Both annoyance and intensity decreased significantly in groups 2 and 3 as compared to group 1, but no significant difference between groups 2 and 3 was found.
This would be important to clarify the following question: Are we dealing with two different populations of SDT patients or do all SDT patients, regardless of the tinnitus's origin (cochlear or central), have a common central pathophysiology?
Alterations of gamma aminobutyric acid (GABA) neuronal function and benzodiazepine receptor (BZR) function in particular have been implicated in the pathophysiology of severe, chronic tinnitus.

The definition of tinnitus is constantly being refined as a result of the integration of information from otolaryngology, psychiatry, neurology, and nuclear medicine. Current hypotheses implicate excitatory amino acid-induced neuroexcitotoxicity and abnormal epileptiform activity [2-5]; hence, antiseizure drugs have been used in the treatment of tinnitus. Using a method of bolus plus constant infusion to establish equilibrium-binding kinetics in the brain allows the performance of accurate quantitative analyses of the density of BZR binding sites in the cortex. Patients were recruited from the Martha Entenmann Tinnitus Research Center-Health Sciences Center, Brooklyn, State University of New York and Forest Hills, NY. Of these patients, two had bilateral tinnitus in the ears, two in the head only, and two in both the head and the ears.
Sterility was confirmed by lack of growth in fluid thioglycolate at 35? and soybean-casein digest at 25? for 2 weeks. We chose these intervals on the basis of previous studies indicating that plasma levels of iomazenil reach steady state by these times [15]. All patient and control images were processed as described (see the section, "Image Analysis") and then imported into a commercial image analysis program (MedX, vol. The results of paired two-tailed comparison of homotypic brain regions with raw counts and V3' levels are described in Table 3. The cerebellum, hippocampus, and thalamic regions did not show any significant asymmetry in receptor density (see Table 3). Cross-sectional appearance of most significant voxels in the two clusters (A, frontal ; E, cerebellar) demonstrating decreased receptor density in subjects with tinnitus. We also compared the SPECT scans of these patients with scans of historically normal control subjects.
The first was a study of region (volume) of interest in which we collected data from brain regions that have been implicated in tinnitus [1,19-22] followed by a voxelbased SPM analysis that would not be biased by our previous concerns about specific area involvement in tinnitus.
We found that the asymmetries identified in the superior temporal region with V3' data matched with our informal visual estimation of asymmetry. The frontal lobe showed the least asymmetry; for the volume-ofinterest assessment, however, this analysis does not account for the symmetrical relative reduction in frontal lobe receptor concentration. Owing to the low number of healthy control iomazenil SPECT scans, we were unable to age- and gender-match our controls exactly to the cases. We cannot, however, exclude that these changes may be in part secondary to reduced affinity of BZR to 123I-iomazenil or to changes in receptor distribution from long-term treatment of the condition with benzodiazepines. What is useful to know, however, is that at the time of the study, all these patients were suffering from tinnitus and that their symptoms had been refractory to treatment. This study, however, should prove to be an effective method on which to base future work and improve our understanding of tinnitus, of its pathophysiology, and of monitoring treatment. This study is the first time that quantification of BZR has been performed on patients with severe, chronic, intractable tinnitus, and it should form a framework for some of the larger studies that could bring to bear an improved description of the natural history of the symptoms and improve treatments. Institute for Neurodegenerative Disorders, New Haven, CT; and5National Institutes of Mental Health, Bethesda, MD.
Our aim was to test the control of SDT of predominantly cochlear origin by benzodiazepines and GABAergic drugs. This finding was consistent with the implication of GABAergic mechanisms in the genesis of SDT of a predominantly central origin. These patients had tinnitus of the severe disabling type for at least 6 months and, in them, treatment with the usual drugs used for tinnitus control had failed.
Otological diagnosis and hearing status were also very similar in the three groups (see Tables 2, 3). Reduced (3H) flunitrazepam binding in singulate cortex and hippocampus of postmortem schizophrenic brains: Is selective loss of glutamatergic neurons associated with major psychoses? GABA-A-benzodiazepine- chloride receptor-targeted therapy for tinnitus control: Preliminary report.
The purpose of our study was to evaluate the distribution of BZR in the brain using 123I-iomazenil single-photon emission computed tomography (SPECT) imaging in patients with severe, intractable central tinnitus. Tinnitus has been attributed to peripheral abnormality in the function of the vestibulocochlear apparatus, to cranial nerve dysfunction, or to central nervous system causes. The therapeutic effect of benzodiazepines in treating tinnitus was studied initially by Melding et al. An intrasubject study comparing nC-iomazenil positron emission tomography (PET) and 123I-iomazenil single-photon emission tomography (SPECT) in healthy subjects demonstrated excellent comparability of these tracers for in vivo assessment of BZR binding [11]. SPECT images were coregistered to the respective magnetic resonance images using Statistical Parametric Mapping (SPM96) [18]. The variability of V3' data in each volume of interest, when compared to the opposite side, was calculated using the Wilcoxon signed rank test.
To the best of our knowledge, this is the first time BZR imaging studies have been performed on patients with severe, chronic central tinnitus. This brought up an interesting question: Were age- and gender-matching of controls actually necessary in iomazenil studies? Neuroprotective drug therapy: A medical and pharmacological treatment for tinnitus control. Changes of benzodiazepine receptors during chronic benzodiazepine administration in humans.
Alterations of benzodiazepine receptors in type II alcoholic subjects measured with SPECT and [123I] Iomazenil.
Decreased benzodiazepine receptor binding in prefrontal cortex in combat-related posttraumatic stress disorder. Quantitation of benzodiazepine receptor binding with PET [11C] Iomazenil and SPECT [123I] Iomazenil: Preliminary results of a direct comparison in healthy human subjects. Formation of 1-[123I] Iodobutane in labeling [123I] Iomazenil by iododestannylation: Implications for the reaction mechanism. Pharmacokinetics of the SPECT benzodiazepine receptor radioligand [123I] Iomazenil in human and non-human primates. SPECT measurement of benzodiazepine receptors in human brain with iodine-123-iomazenil: Kinetic and equilibrium paradigms. Evaluation of ultrafiltration for the free-fraction determination of single photon emission computed tomography (SPECT) radiotracers: beta-CIT, IBF, and iomazenil. Focal metabolic activation in the predominant left auditory cortex in patients suffering from tinnitus a PET study with [18F] deoxyglucose.

No age-related changes in human benzodiazepine receptor binding measured by PET with [11C] Ro 15-4513.
We followed the format of a prospective, randomized, singleblind clinical trial at an academic tertiary-care hospital.
A rationale for the treatment of the symptom with benzodiazepines and GABAergic drugs was based on these results.
He treated 30 patients, all having SDT with a predominantly central origin and showing perfusion changes in areas of interest in the brain as documented by SPECT. Patients who had tinnitus as a consequence of otological surgery, who had chronic otitis media, or who had medical contraindications for the use of benzodiazepines and GABAergic drugs were excluded. Our patients had SDT associated with otological diseases that are known to produce tinnitus. Six patients with severe intractable tinnitus received a bolus and constant infusion of 123I-iomazenil intravenously over 7 hours with SPECT and magnetic resonance imaging of the brain. According to the American Tinnitus Association, approximately 50 million people are affected with tinnitus in the United States. The purpose of our study was to apply these techniques to evaluate cortical BZR using 123I-iomazenil SPECT imaging in patients with severe, central-type tinnitus as compared with healthy age-matched controls.
Patients were excluded from the study for (1) pregnancy, (2) neurological or axis I psychiatric illness, (3) significant medical disease, (4) intake of medications known to affect GABA or BZR in 2 weeks before radiopharmaceutical administration, and (5) alcohol or psychotropic drug use within 2 weeks before the SPECT study. All patients received potassium iodide (0.6 g SSKI solution) in the 24-hour period before the scan. An operational method for a standardized region-ofinterest strategy was developed by consensus of two experienced research nuclear medicine physicians, and regions of interest were placed. The V3' value for the radiotracer in each region of interest was calculated using the free fraction of the parent.
The findings of this study do not correlate with the current understanding of tinnitus, which indicates a possible seat of pathology in the temporal lobes [1,19,23,24]. In 16 healthy volunteers aged 21-78 years and studied with 11C-RO-4513 PET, no significant change with age was seen in 10 brain regions studied [26]. Abnormalities of benzodiazepine receptors have been demonstrated in Alzheimer's disease, Huntington's chorea, schizophrenia, and stress [2-6].
Twenty-one patients completed the trial and, of these, 19 had significant improvement of the symptom and increased brain perfusion, documented by SPECT, after the treatment. Therefore, it is reasonable to say that their symptom was of a predominantly cochlear origin.
The VAS alone may not be able to distinguish between sensory (intensity) and affect (annoyance) components of SDT. After magnetic resonance imaging coregistration, standardized regions of interest were placed over the cerebellar, frontal (control), superior temporal, hippocampal, and thalamic regions bilaterally on (SPECT) images. Twelve control subjects were selected from a database of healthy controls with no lifetime psychiatric diagnosis and no clinically significant medical or neurological history, including tinnitus, on the basis of physical examination and laboratory studies.
The mean bolus-to-infusion ratios were comparable to those from our previous studies, where they were shown to be optimal in achieving steady state of parent compound and unchanging time-activity curves in cortex [15]. The a priori hypothesis in this preliminary investigation was that chronic tinnitus would show abnormalities in the cerebellum, hippocampus, temporal lobes, and thalamic nuclei [19]. At an earlier stage of this project, we noted a trend showing decreased receptor density in the right cerebellum [25]; however, since then, we have reanalyzed data with closer age matching and also using newer image-processing techniques. Also, correlation between 123I-iomazenil SPECT and 11C-iomazenil PET studies has been good [11]; however, in both these studies, only a bolus injection of the tracer was performed, which does not necessarily produce equilibrium binding offered by the bolus and constant infusion method used in our study. We treated 10 patients with placebo (group 1), 10 with benzodiazepine drugs (group 2), and 10 with benzodiazepine and GABAergic drugs (group 3).
Venous blood samples were drawn at specified intervals to determine equilibrium distribution volumes (V3') for each of the regions. This procedure was repeated for each patient, and correction to the time of injection was performed. Imaging was started on average within 345 ± 19 minutes and 363 ± 3 8 minutes after bolus radiotracer administration, respectively, for cases and controls. The study group (n = 6) was compared to the control group (n = 12) using a two-sample t-test for areas of relative increase or decrease in radiotracer accumulation. We recorded a decrease in the annoyance and intensity of SDT as measured by a visual analog scale ranging from 1 (negligible) to 10 (unbearable).
Variation in V3' values in homotypic regions were calculated using a Wilcoxon signed rank test.
The extent threshold (k), below which clusters were rejected, was 125 voxels, which corresponds to the approximate resolution of SPECT imaging in tissue, which is 1 mm3. We found statistically significant improvement in comparing groups 2 and 3 with group 1 but found no significant difference when groups 2 and 3 were compared.
Twelve normal control subjects were compared to the study subjects using statistical parametric mapping.
Control subject images were acquired by three serial 18-minute scans that were summed before being used in image analysis. Addition of GABAergic to benzodiazepine drugs does not modify the treatment results in SDT of a predominantly cochlear origin. Comparison of homotypic brain regions showed statistically significant asymmetry in the V3' data in the superior temporal cortex (p = .03 for both).
All tinnitus patients underwent MRI and coregistration with SPECT scans (as described later) for directing region-of-interest placement.
Current understanding suggests GABA receptors and the temporal lobe system as the final common pathway. This pilot study suggests possible alterations on 123I-iomazenil SPECT imaging and the need for larger studies.

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