Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus

Study Overview
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Brief Summary
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Relating the electroencephalogram findings of patients with tinnitus before and after a therapeutic modality is still scarce in the literature, especially with neuromodulatory methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n = 18) will be recruited for comparative purposes of brain electrical activity with and without tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale - VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be performed after 1 month of the end of treatment with tDCS.

Official Title
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IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation
* Device: Sham Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 18 years; Chronic tinnitus for at least 6 months. Age-adjusted normal (sensorineural) hearing Exclusion Criteria: Pregnancy and/or lactation; Concurrent treatment for tinnitus; Prior exposure to transcranial direct current stimulation (tDCS); History of epilepsy and/or seizures; Electronic implants or metallic objects in body; Skin conditions where electrodes will be applied; Major neurological co-morbidities.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br>Subjects will receive 20 minutes of active tDCS for five consecutive days, current of 2 mA, in the temporoparietal left area, and right prefrontal cortex. | Device: Transcranial Direct Current Stimulation<br>* Anodal stimulation of the temporoparietal left area with an cathode over the right dorsolateral prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.<br>* Other names: Direct current stimulator; Transcranial stimulator;|
| Sham Comparator: Sham tDCS<br>Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex. | Device: Sham Transcranial Direct Current Stimulation<br>* Sham tDCS sessions will last 20 minutes<br>* Other names: Sham stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory | Assesses change in tinnitus from baseline to follow-up periods post interventions | THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress | Self assessment of tinnitus loudness and tinnitus distress. | Visual analogue scale of tinnitus wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention. | 
| Acuphenometry | Subjective assessment of the frequency, intensity and type of tinnitus. | Acufhenometry wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, Electroencephalogram, Transcranial Direct Current Stimulation