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Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial.

ABSTRACT: Recent research indicates that tinnitus is related to alterations of neural networks including temporal, parietal, and prefrontal brain regions. The current study examines a rTMS protocol which targets three central nodes of these networks in a two-arm randomized parallel group trial. Overall, 49 patients with chronic tinnitus were randomized to receive either triple-site stimulation (left dorsolateral prefrontal stimulation, 1000?pulses, 20?Hz plus left and right temporoparietal stimulation, 1000 pulses each, 1?Hz) or single-site stimulation (left temporoparietal stimulation, 3000?pulses, 1?Hz). Both groups were treated in ten sessions. Tinnitus severity as measured by the tinnitus questionnaire was assessed before rTMS (day1), after rTMS (day12) and at two follow-up visits (day 90 and day 180). The triple-site protocol was well tolerated. There was a significant reduction in tinnitus severity for both treatment groups. The triple-site group tended to show a more pronounced treatment effect at day 90. However, the measurement time point x group interaction effect was not significant. The current results confirm former studies that indicated a significant reduction of tinnitus severity after rTMS treatment. No significant superiority of the multisite protocol was observed. Future approaches for the enhancement of treatment effects are discussed.

SUBMITTER: Lehner A

PROVIDER: S-EPMC4772792 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial.

Lehner Astrid A Schecklmann Martin M Greenlee Mark W MW Rupprecht Rainer R Langguth Berthold B

Scientific reports 20160301

Recent research indicates that tinnitus is related to alterations of neural networks including temporal, parietal, and prefrontal brain regions. The current study examines a rTMS protocol which targets three central nodes of these networks in a two-arm randomized parallel group trial. Overall, 49 patients with chronic tinnitus were randomized to receive either triple-site stimulation (left dorsolateral prefrontal stimulation, 1000 pulses, 20 Hz plus left and right temporoparietal stimulation, 10 ...[more]

PMID: 26927363

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Project description:Several years ago, repetitive transcranial magnetic stimulation (rTMS) of the auditory cortex has been introduced as a treatment approach for chronic tinnitus. Even if this treatment is beneficial for a subgroup of patients, the overall effects are limited. This limitation may be due to the fact that the auditory cortex is only one of several brain areas involved in tinnitus. Whereas auditory areas are considered to code for tinnitus loudness, conscious perception of and attention allocation to tinnitus is supposed to be reflected by network activity involving frontal and parietal cortical areas. The aim of the present study is to influence this frontoparietal network more efficiently by perturbing the most important nodes with rTMS.This is a randomized, double-blind, parallel-group study. Patients receive rTMS treatment on 10 consecutive working days using either the multisite rTMS protocol (left dorsolateral prefrontal, 1,000 stimuli, 20 Hz; left temporoparietal, 1,000 stimuli, 1 Hz; right temporoparietal stimulation, 1,000 stimuli, 1 Hz) or a single-site protocol (unilateral stimulation of the temporoparietal cortex, 3,000 stimuli, 1 Hz). Individuals aged 18 to 70 years with chronic tinnitus ?6-month duration and a Tinnitus Handicap Inventory score ?38 are recruited for the study. A total of 50 patients are needed to detect a clinical relevant change of tinnitus severity (??=?0.05; 1 - ??=?0.80). Primary outcome measures are the change in the Tinnitus Questionnaire score from baseline to the end of treatment as well as the number of treatment responders as defined by a reduction in the Tinnitus Questionnaire score of ?5 points. Furthermore, changes in brain structure and activity are assessed using (functional) magnetic resonance imaging and electroencephalography in the resting state. Those measurements are also performed in 25 healthy control subjects.This study is designed to reveal whether network stimulation is superior to single-site stimulation in the treatment of chronic tinnitus. Furthermore, the comparison between tinnitus patients and healthy controls and the longitudinal effects of both rTMS treatment protocols on brain structure and function allow inferences to be made about the neural correlates of tinnitus.Clinical Trials: NCT01663324.

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:Neuromodulation technologies, such as transcranial magnetic stimulation (TMS), are promising tools for neurorehabilitation, aphasia therapy included, but not yet in common clinical use. Combined with behavioral techniques, in particular treatment-efficient Intensive Language-Action Therapy (ILAT, previously CIAT or CILT), TMS could substantially amplify the beneficial effect of such behavioral therapy alone (Thiel et al., 2013; Martin et al., 2014; Mendoza et al., 2016; Kapoor, 2017). In this randomized study of 17 subjects with post-stroke aphasia in the chronic stage, we studied the combined effect of ILAT and 1-Hz placebo-controlled navigated repetitive TMS (rTMS) to the right-hemispheric inferior frontal cortex-that is, to the anterior part of the non-dominant hemisphere's homolog Broca's area (pars triangularis). Patients were randomized to groups A and B. Patients in group A received a 2-week period of rTMS during naming training where they named pictures displayed on the screen once every 10 s, followed by 2 weeks of rTMS and naming combined with ILAT. Patients in group B received the same behavioral therapy but TMS was replaced by sham stimulation. The primary outcome measures for changes in language performance were the Western Aphasia Battery's aphasia quotient AQ; the secondary outcome measures were the Boston naming test (BNT) and the Action naming test (Action BNT, ANT). All subjects completed the study. At baseline, no statistically significant group differences were discovered for age, post-stroke time or diagnosis. ILAT was associated with significant improvement across groups, as documented by both primary and secondary outcome measures. No significant effect of rTMS could be documented. Our results agree with previous results proving ILAT's ability to improve language in patients with chronic aphasia. In contrast with earlier claims, however, a beneficial effect of rTMS in chronic post-stroke aphasia rehabilitation was not detected in this study. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03629665.

Project description:BACKGROUND:Chronic tinnitus is a highly prevalent symptom, with many patients reporting considerable effects of tinnitus on quality of life. No clear evidence-based treatment options are currently available. While counseling-based methods are valuable in some cases, they are not sufficiently effective for all tinnitus patients. Neuromodulation techniques such as high-definition transcranial direct current stimulation (HD-tDCS) are proposed to have positive effects on tinnitus severity but, to date, these effects have not been proven conclusively. The proposed trial will investigate the hypothesis that chronic tinnitus patients receiving HD-tDCS will report a positive effect on the impact of tinnitus on daily life, as compared to patients receiving sham stimulation. METHODS:This study proposes a randomized, double-blind, placebo-controlled trial with parallel group design. A total of 100 chronic tinnitus patients will be randomly allocated to an experimental group or a sham group, with allocation stratified according to gender and tinnitus severity. Patient and researcher will be blinded to the patient's allocation. Patients will undergo six sessions of sequential dual-site HD-tDCS of the left temporal area and the right dorsolateral prefrontal cortex. Evaluations will take place at baseline, immediately following treatment, and at three and six months after the start of the therapy. The primary outcome measure is the change in Tinnitus Functional Index (TFI) score. Secondary outcome measures include audiological measurements, cortical auditory evoked potentials, the Repeatable Battery for the Assessment of Neuropsychological Status adjusted for hearing-impaired individuals (RBANS-H), and supplementary questionnaires probing tinnitus severity and additional symptoms. By use of a linear regression model, the effects of HD-tDCS compared to sham stimulation will be assessed. DISCUSSION:The objective of this study is to evaluate whether HD-tDCS can reduce the impact of tinnitus on daily life in chronic tinnitus patients. To date, published trials on the effects of HD-tDCS on tinnitus suffer from a lack of standardization and few randomized controlled trials exist. The proposed study will be the first adequately powered trial to investigate the effects of sequential dual-site HD-tDCS on tinnitus severity. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03754127 . Registered on 22 November 2018.

Project description:IntroductionTinnitus is an intrusive and chronic illness affecting a significant portion of the population, decreasing affected individuals' quality of life and socioeconomic functioning. Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes. Several studies have proven its effect on tinnitus. We aimed to broaden the knowledge and provide data on the effect and its retention.MethodsIn the randomized, double-blinded, sham-controlled trial, 39 patients (active n = 19, sham n = 20) underwent bifrontal tDCS (anode over right dorsolateral prefrontal cortex (DLPFC), cathode left DLPFC, current of 1.5 mA, 20 min, 6 sessions in 2 weeks). Tinnitus Functional Index (TFI), Iowa Tinnitus Handicap Questionnaire (ITHQ), Beck Anxiety Inventory (BAI), Zung Self-Rating Depression Scale (SDS), and WHO-Quality of Life-BREF were employed in 4 evaluation points, including the follow-ups of 6 weeks and 6 months.ResultsWe reached a delayed, significant long-term improvement (p < 0.05) in auditory difficulties associated with tinnitus and noticed it even after 6 months compared to placebo. We also reached a short-term, negative effect in the psychological domain of WHO-Quality of Life-BREF (p < 0.05). Not all subdomains of TFI and ITHQ reached statistical significance during the data analysis, even though specific positive trends were noticed.ConclusionWe proved partial, positive, long-term effects of tDCS on tinnitus and short-term, negative, transient effect on a specific aspect of the general quality of life. We expanded upon the results of previous trials and provided data concerning the longevity and the precise effect of multiple sessions, bifrontal DLPFC tDCS. Our sample size (n = 39) was limited, which might have contributed to the lesser statistical power of the analyzed items.Clinical trial registration[www.ClinicalTrials.gov], identifier [NCT05437185].

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:BackgroundTinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus.MethodsThirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22). Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ).ResultsANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010). Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p < 0.001; control group: t = 2.5; df = 16; p = 0.023), but the intervention group improved more than the control group. Groups differed at week 7 and 9, but not at week 24 as far as the TQ score was concerned.ConclusionsOur results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes.The study is registered with clinicaltrials.gov (NCT01540357).

Dataset Information

Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial.

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Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial.

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