HD-tDCS as a Treatment for Chronic Tinnitus

Study Overview
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Brief Summary
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Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.

Official Title
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High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Chronic Tinnitus: Outcomes From a Prospective Longitudinal Large Cohort Study

Conditions
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Tinnitus, Subjective

Intervention / Treatment
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* Device: High Definition transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic, subjective, non-pulsatile tinnitus met the criteria for HD-tDCS safety Exclusion Criteria: a middle ear pathology another tinnitus treatment ongoing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD-tDCS<br>Each patient received a total of six sessions of anodal HD-tDCS of right DLPFC. | Device: High Definition transcranial Direct Current Stimulation<br>* 1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Functional Index (TFI) | Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue scale (VAS) for tinnitus loudness | Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | 
| Change in Hospital Anxiety and Depression Scale (HADS) | Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder. Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | 
| Change in Tinnitus Questionnaire (TQ) | Tinnitus severity self-report questionnaire, ranging from 0-84 with a higher score representing a more distressing tinnitus | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | 
| Change in Hyperacusis Questionnaire (HQ) | Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity. | Baseline (before intervention), immediately post intervention, 7 weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large cohort, non-invasive brain stimulation, tinnitus, neuromodulation, transcranial direct current stimulation, high-definition tDCS