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The purpose of this study is to determine if repeated sessions of transcranial direct current stimulation (tDCS) are effective for treating chronic subjective tinnitus. Previous studies have reported brief improvements in tinnitus after safe and noninvasive stimulation of the auditory cortex or limbic system. The investigators hypothesize that a greater improvement in tinnitus will be achieved following repeated sessions of tDCS that target both auditory and limbic systems.
Subjective tinnitus is a distressing condition characterized by the sensation of sound or noise in the absence of internal or external stimuli. Research indicates that tinnitus may develop due to maladaptive plastic changes in the auditory cortex and limbic system. These changes can be targeted using safe and noninvasive brain stimulation techniques like transcranial direct current stimulation (tDCS). TDCS alters the excitability of the cortex using a weak direct current and may lead to long-term plastic changes, making it a potential therapeutic tool for the treatment of tinnitus.
Transient improvements in tinnitus have been reported after inhibitory stimulation of the auditory cortex and after excitatory stimulation of the prefrontal cortex, however the effects of a combined stimulation paradigm remain unknown. The investigators hypothesize that a cumulative effect will be observed following repeated sessions of tDCS by modulating both the excitability of the auditory cortex and prefrontal cortex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Active Comparator | Subjects will receive 20 minutes of active tDCS. |
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| Sham tDCS | Sham Comparator | Subjects will receive 20 minutes of sham tDCS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainSTIM Transcranial Stimulator | Device | Cathodal stimulation of the auditory cortex with an anode (reference electrode) over the prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA. |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-Bédikian et al., 2010) | Assesses the change in tinnitus from baseline to 1 month after intervention. | Baseline, 1 month after last intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Handicap Inventory (THI) | Assesses change in tinnitus from baseline to follow-up periods post interventions. | Baseline, session 5 (day 5), 1 and 3 months after the last intervention |
| Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Benninger, MD | Centre Hospitalier Universitaire Vaudois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| BrainSTIM Transcranial Stimulator | Device | Sham tDCS sessions will last 20 minutes. |
|
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Self assessment of tinnitus loudness and tinnitus distress. |
| Baseline, before and after each intervention, 1 and 3 months after the last intervention |
| Hospital Anxiety and Depression Scale (HAD) | Assesses anxiety and depression. | Baseline, 1 month after intervention |
| Subjective Tinnitus Severity Scale (STSS) | Assesses tinnitus severity. | Baseline, session 5 (day 5), 1 and 3 months after the last intervention |
| Clinical Global Impression Scale (CGI) | Patient rating of worsening/improvement in condition following interventions. | Session 5 (day 5), 1 and 3 months after the last intervention |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |