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Transcranial magnetic stimulation for tinnitus: using the Tinnitus Functional Index to predict benefit in a randomized controlled trial.

ABSTRACT: Identifying characteristics associated with transcranial magnetic stimulation (TMS) benefit would offer insight as to why some individuals experience tinnitus relief following TMS treatment, whereas others do not. The purpose of this study was to use the Tinnitus Functional Index (TFI) and its subscales to identify specific factors associated with TMS treatment responsiveness.Individuals with bothersome tinnitus underwent 2000 pulses of 1-Hz TMS for 10 consecutive business days. The primary outcome measure was the TFI which yields a total score and eight individual subscale scores. Analyses were performed on baseline data from the active arm (n?=?35) of a prospective, double-blind, randomized placebo-controlled clinical trial of TMS for tinnitus.Baseline total TFI score and three of the eight TFI subscales were useful in differentiating between responders and nonresponders to TMS intervention for tinnitus. These findings are not definitive, but suggest potential factors that contribute to perceived benefit following TMS.Overall, the main factor associated with TMS benefit was a higher tinnitus severity score for responders at baseline. The TFI subscales helped to clarify the factors that contributed to a higher severity score at baseline. Large-scale prospective research using systematic approaches is needed to identify and describe additional factors associated with tinnitus benefit following TMS.ClinicalTrials.gov, ID: NCT01104207 . Registered on 13 April 2010.

SUBMITTER: Theodoroff SM

PROVIDER: S-EPMC5301432 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Transcranial magnetic stimulation for tinnitus: using the Tinnitus Functional Index to predict benefit in a randomized controlled trial.

Theodoroff Sarah M SM Griest Susan E SE Folmer Robert L RL

Trials 20170209 1

<h4>Background</h4>Identifying characteristics associated with transcranial magnetic stimulation (TMS) benefit would offer insight as to why some individuals experience tinnitus relief following TMS treatment, whereas others do not. The purpose of this study was to use the Tinnitus Functional Index (TFI) and its subscales to identify specific factors associated with TMS treatment responsiveness.<h4>Methods</h4>Individuals with bothersome tinnitus underwent 2000 pulses of 1-Hz TMS for 10 consecut ...[more]

PMID: 28183355

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Project description:Transcranial direct current stimulation (tDCS) has been proposed as a potential intervention for subjective tinnitus, but supporting evidence remains limited. We aimed to investigate the effect of anodal high-definition tDCS of the left temporal area and right dorsolateral prefrontal cortex on tinnitus severity. This double-blind randomized controlled trial included 77 patients (age range 18-79, 43 male) with chronic subjective tinnitus as their primary complaint. Thirty-eight subjects received six consecutive sessions of dual-site sequential high-definition-tDCS with electrodes positioned over the left temporal area and right dorsolateral prefrontal cortex. Both areas were stimulated for 15 min per session, with total stimulation time amounting to 30 min. Thirty-nine subjects received sham stimulation. The primary outcome measure was the change in tinnitus severity, as evaluated by the Tinnitus Functional Index, from baseline to a follow-up visit at 8 ± 2 weeks after treatment completion. Secondary outcomes included changes in perceived tinnitus loudness, as measured with a visual analogue scale and a tinnitus matching procedure, as well as scores on the Hospital Anxiety and Depression Scale, and the Hyperacusis Questionnaire. No differences in Tinnitus Functional Index change scores were identified between the active treatment and sham control groups (linear regression: P = 0.86). The Tinnitus Functional Index scores decreased significantly over time in both groups (P = 0.0012), indicating the presence of a considerable placebo effect. These change scores were significantly influenced by sex (linear regression: P = 0.037) and baseline symptoms of anxiety (linear regression: P = 0.049) in both groups. In general, Tinnitus Functional Index scores decreased more profoundly in males and in subjects with a higher degree of anxiety at baseline. None of the included secondary measures differed significantly between experimental arms. Our results suggest that dual-site sequential high-definition-tDCS of the left temporal area and right dorsolateral prefrontal cortex does not alleviate tinnitus severity. Interestingly, in our study population, fluctuations in tinnitus severity were influenced by gender and concurrent mental condition. It is therefore important to take these factors into account when conducting or planning randomized controlled trials in tinnitus populations.

Project description:Chronic tinnitus is associated with neuroplastic changes in auditory and non-auditory cortical areas. About 10 years ago, repetitive transcranial magnetic stimulation (rTMS) of auditory and prefrontal cortex was introduced as potential treatment for tinnitus. The resulting changes in tinnitus loudness are interpreted in the context of rTMS induced activity changes (neuroplasticity). Here, we investigate the effect of single rTMS sessions on oscillatory power to probe the capacity of rTMS to interfere with tinnitus-specific cortical plasticity. We measured 20 patients with bilateral chronic tinnitus and 20 healthy controls comparable for age, sex, handedness, and hearing level with a 63-channel electroencephalography (EEG) system. Educational level, intelligence, depressivity and hyperacusis were controlled for by analysis of covariance. Different rTMS protocols were tested: Left and right temporal and left and right prefrontal cortices were each stimulated with 200 pulses at 1 Hz and with an intensity of 60% stimulator output. Stimulation of central parietal cortex with 6-fold reduced intensity (inverted passive-cooled coil) served as sham condition. Before and after each rTMS protocol 5 min of resting state EEG were recorded. The order of rTMS protocols was randomized over two sessions with 1 week interval in between. Analyses on electrode level showed that people with and without tinnitus differed in their response to left temporal and right frontal stimulation. In tinnitus patients left temporal rTMS decreased frontal theta and delta and increased beta2 power, whereas right frontal rTMS decreased right temporal beta3 and gamma power. No changes or increases were observed in the control group. Only non-systematic changes in tinnitus loudness were induced by single sessions of rTMS. This is the first study to show tinnitus-related alterations of neuroplasticity that were specific to stimulation site and oscillatory frequency. The observed effects can be interpreted within the thalamocortical dysrhythmia model assuming that slow waves represent processes of deafferentiation and that high frequencies might be indicators for tinnitus loudness. Moreover our findings confirm the role of the left temporal and the right frontal areas as relevant hubs in tinnitus related neuronal network. Our results underscore the value of combined TMS-EEG measurements for investigating disease related changes in neuroplasticity.

Project description:OBJECTIVES:Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the temporal cortex has been investigated as a new treatment tool for chronic tinnitus during the last years and has shown moderate efficacy. However, there is growing evidence that tinnitus is not a pathology of a specific brain region, but rather the result of network dysfunction involving both auditory and non-auditory brain regions. In functional imaging studies the right dorsolateral prefrontal cortex has been identified as an important hub in tinnitus related networks and has been shown to particularly reflect the affective components of tinnitus. Based on these findings we aimed to investigate whether the effects of left low-frequency rTMS can be enhanced by antecedent right prefrontal low-frequency rTMS. STUDY DESIGN:Fifty-six patients were randomized to receive either low-frequency left temporal rTMS or a combination of low-frequency right prefrontal followed by low-frequency left temporal rTMS. The change of the tinnitus questionnaire (TQ) score was the primary outcome, secondary outcome parameters included the Tinnitus Handicap Inventory, numeric rating scales, and the Beck Depression Inventory. The study is registered in clinicaltrials.gov (NCT01261949). RESULTS:Directly after therapy there was a significant improvement of the TQ-score in both groups. Comparison of both groups revealed a trend toward more pronounced effects for the combined group (effect size: Cohen's d?=?0.176), but this effect did not reach significance. A persistent trend toward better efficacy was also observed in all other outcome criteria. CONCLUSION:Additional stimulation of the right prefrontal cortex seems to be a promising strategy for enhancing TMS effects over the temporal cortex. These results further support the involvement of the right DLPFC in the pathophysiology of tinnitus. The small effect size might be due to the study design comparing the protocol to an active control condition.

Project description:BackgroundChronic tinnitus affects approximately 10-15% of the population. Low-frequency repetitive transcranial magnetic stimulation (rTMS) has been considered as a promising and well-tolerated therapeutic strategy for chronic tinnitus. However, a recent large-scale multicenter clinical trial showed a negative result.ObjectiveThis systematic review is aimed at assessing the efficacy and safety of low-frequency rTMS in chronic tinnitus.MethodsWe searched PubMed, Embase, and Cochrane Library for randomized controlled studies of rTMS treatment of chronic tinnitus. A pooled analysis of standardized mean difference (SMD) was performed with 95% confidence intervals (CI).ResultsTen RCTs involving 567 participants were included in this review. Compared with sham stimulation, rTMS showed no significant efficacy in tinnitus severity and disability measured by Tinnitus Handicap Inventory (THI) in short-term (SMD = -0.04, 95% CI -0.23 to 0.16, P = 0.72), medium-term (SMD = -0.13, 95% CI -0.43 to 0.17, P = 0.41), and long-term (SMD = -0.16, 95% CI -0.38 to 0.05, P = 0.14) follow-up. Tinnitus severity and disability measured by Tinnitus Questionnaire (TQ) also showed no significant improvement in short-term (SMD = -0.11, 95% CI -0.31 to 0.10, P = 0.30), medium-term (SMD = -0.10, 95% CI -0.37 to 0.16, P = 0.44), and long-term (SMD = -0.20, 95% CI -0.40 to 0.01, P = 0.06) follow-up. Additionally, no statistically significant difference was shown in the changes of tinnitus loudness assessed by a visual analogue scale (VAS) between rTMS and sham groups in the short-term (SMD = -0.28, 95% CI -0.59 to 0.02, P = 0.07), medium-term (SMD = -0.26, 95% CI -0.59 to 0.07, P = 0.13), and long-term (SMD = -0.20, 95% CI -0.53 to 0.13, P = 0.24) follow-up. Few mild or moderate adverse events were observed in both the rTMS and sham groups.ConclusionLow-frequency rTMS is well tolerated but not effective in treating chronic tinnitus based on the current analysis of pooled data. Further studies with modified and uniform protocols are required to investigate the potential benefit of rTMS in chronic tinnitus.

Dataset Information

Transcranial magnetic stimulation for tinnitus: using the Tinnitus Functional Index to predict benefit in a randomized controlled trial.

Publications

Transcranial magnetic stimulation for tinnitus: using the Tinnitus Functional Index to predict benefit in a randomized controlled trial.

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