Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus
Primary Purpose
Tinnitus
Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
BrainSTIM Transcranial Stimulator
BrainSTIM Transcranial Stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Transcranial direct current stimulation, Transcranial magnetic stimulation
Eligibility Criteria
Inclusion Criteria:
- Age of at least 18 years
- Chronic tinnitus for at least 1 year
- Diagnosis of chronic subjective non-pulsatile tinnitus
- Age-adjusted normal (sensorineural) hearing
- Score of 25 or above on the Mini-mental state examination (MMSE)
- Must comply with use of contraceptives during interventions
Exclusion Criteria:
- Objective tinnitus
- Concurrent treatment for tinnitus
- Prior exposure to transcranial direct current stimulation (tDCS)
- Electronic implants or metallic objects in body, including cardiac pacemakers, cochlear implants, implanted medical pump, metal plate in skull, metal implant in the skull or eyes (other than dental appliances or fillings)
- Skin conditions where electrodes will be applied
- Major neurological co-morbidities
- History of epilepsy and/or seizures
- Pregnancy and/or lactation
Sites / Locations
- Department of Neurology, Centre Hospitalier Universitaire Vaudois
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
Subjects will receive 20 minutes of active tDCS.
Subjects will receive 20 minutes of sham tDCS.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Tinnitus Handicap Inventory (THI)
Assesses change in tinnitus from baseline to follow-up periods post interventions.
Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
Self assessment of tinnitus loudness and tinnitus distress.
Hospital Anxiety and Depression Scale (HAD)
Assesses anxiety and depression.
Subjective Tinnitus Severity Scale (STSS)
Assesses tinnitus severity.
Clinical Global Impression Scale (CGI)
Patient rating of worsening/improvement in condition following interventions.
Full Information
NCT ID
NCT01575496
First Posted
April 10, 2012
Last Updated
August 1, 2012
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT01575496
Brief Title
Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus
Official Title
Transcranial Direct Current Stimulation (tDCS) for the Treatment of Chronic Subjective Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Transcranial direct current stimulation, Transcranial magnetic stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Subjects will receive 20 minutes of active tDCS.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Subjects will receive 20 minutes of sham tDCS.
Intervention Type
Device
Intervention Name(s)
BrainSTIM Transcranial Stimulator
Other Intervention Name(s)
Cathodal tDCS, Bilateral tDCS, Direct current stimulator, Transcranial stimulator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
BrainSTIM Transcranial Stimulator
Other Intervention Name(s)
Sham stimulation, Direct current stimulator, Transcranial stimulator
Intervention Description
Sham tDCS sessions will last 20 minutes.
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-Bédikian et al., 2010)
Description
Assesses the change in tinnitus from baseline to 1 month after intervention.
Time Frame
Baseline, 1 month after last intervention
Secondary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
Assesses change in tinnitus from baseline to follow-up periods post interventions.
Time Frame
Baseline, session 5 (day 5), 1 and 3 months after the last intervention
Title
Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
Description
Self assessment of tinnitus loudness and tinnitus distress.
Time Frame
Baseline, before and after each intervention, 1 and 3 months after the last intervention
Title
Hospital Anxiety and Depression Scale (HAD)
Description
Assesses anxiety and depression.
Time Frame
Baseline, 1 month after intervention
Title
Subjective Tinnitus Severity Scale (STSS)
Description
Assesses tinnitus severity.
Time Frame
Baseline, session 5 (day 5), 1 and 3 months after the last intervention
Title
Clinical Global Impression Scale (CGI)
Description
Patient rating of worsening/improvement in condition following interventions.
Time Frame
Session 5 (day 5), 1 and 3 months after the last intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of at least 18 years
Chronic tinnitus for at least 1 year
Diagnosis of chronic subjective non-pulsatile tinnitus
Age-adjusted normal (sensorineural) hearing
Score of 25 or above on the Mini-mental state examination (MMSE)
Must comply with use of contraceptives during interventions
Exclusion Criteria:
Objective tinnitus
Concurrent treatment for tinnitus
Prior exposure to transcranial direct current stimulation (tDCS)
Electronic implants or metallic objects in body, including cardiac pacemakers, cochlear implants, implanted medical pump, metal plate in skull, metal implant in the skull or eyes (other than dental appliances or fillings)
Skin conditions where electrodes will be applied
Major neurological co-morbidities
History of epilepsy and/or seizures
Pregnancy and/or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Benninger, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus
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