Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus
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|ClinicalTrials.gov Identifier: NCT01575496|
Recruitment Status : Unknown
Verified August 2012 by David Benninger, MD, Centre Hospitalier Universitaire Vaudois.
Recruitment status was: Enrolling by invitation
First Posted : April 11, 2012
Last Update Posted : August 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: BrainSTIM Transcranial Stimulator||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Transcranial Direct Current Stimulation (tDCS) for the Treatment of Chronic Subjective Tinnitus|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||January 2015|
Active Comparator: Active tDCS
Subjects will receive 20 minutes of active tDCS.
Device: BrainSTIM Transcranial Stimulator
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.
Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of sham tDCS.
Device: BrainSTIM Transcranial Stimulator
Sham tDCS sessions will last 20 minutes.
- Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-Bédikian et al., 2010) [ Time Frame: Baseline, 1 month after last intervention ]Assesses the change in tinnitus from baseline to 1 month after intervention.
- Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention ]Assesses change in tinnitus from baseline to follow-up periods post interventions.
- Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress [ Time Frame: Baseline, before and after each intervention, 1 and 3 months after the last intervention ]Self assessment of tinnitus loudness and tinnitus distress.
- Hospital Anxiety and Depression Scale (HAD) [ Time Frame: Baseline, 1 month after intervention ]Assesses anxiety and depression.
- Subjective Tinnitus Severity Scale (STSS) [ Time Frame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention ]Assesses tinnitus severity.
- Clinical Global Impression Scale (CGI) [ Time Frame: Session 5 (day 5), 1 and 3 months after the last intervention ]Patient rating of worsening/improvement in condition following interventions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575496
|Department of Neurology, Centre Hospitalier Universitaire Vaudois|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||David Benninger, MD||Centre Hospitalier Universitaire Vaudois|