TinnitusPhase 2NCT01575496
Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus
A Phase 2 study testing BrainSTIM Transcranial Stimulator in people with Tinnitus, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- BrainSTIM Transcranial Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) for the Treatment of Chronic Subjective Tinnitus
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- BrainSTIM Transcranial Stimulator
- Keywords
- Tinnitus, Transcranial direct current stimulation, Transcranial magnetic stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainSTIM Transcranial StimulatorDevice
Also called Cathodal tDCS, Bilateral tDCS, Direct current stimulator, 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.
BrainSTIM Transcranial StimulatorDevice
Also called Sham stimulation, Direct current stimulator, Transcranial stimulator
Sham tDCS sessions will last 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Subjects will receive 20 minutes of active tDCS. Receives: Device: BrainSTIM Transcranial Stimulator |
| Sham tDCS | Sham comparator | Subjects will receive 20 minutes of sham tDCS. Receives: Device: BrainSTIM Transcranial Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month after last intervention
Secondary outcomes (5)
Tinnitus Handicap Inventory (THI)
Assesses change in tinnitus from baseline to follow-up periods post interventions.
Measured: Baseline, session 5 (day 5), 1 and 3 months after the last intervention
Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
Self assessment of tinnitus loudness and tinnitus distress.
Measured: Baseline, before and after each intervention, 1 and 3 months after the last intervention
Hospital Anxiety and Depression Scale (HAD)
Assesses anxiety and depression.
Measured: Baseline, 1 month after intervention
Subjective Tinnitus Severity Scale (STSS)
Assesses tinnitus severity.
Measured: 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.
Measured: Session 5 (day 5), 1 and 3 months after the last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Benninger, MD, Centre Hospitalier Universitaire Vaudois
- Investigators
- David Benninger, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575496
- Sponsor's protocol ID
- CIV-12-02-004761
- Status last verified
- Aug 2012
- First submitted
- 10 Apr 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) for the Treatment of Chronic Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT01575496
- Acronym / sponsor ID
- CIV-12-02-004761
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Transcranial direct current stimulation, Transcranial magnetic stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2015 (estimated)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: BrainSTIM Transcranial StimulatorSubjects will receive 20 minutes of active tDCS. |
| Sham tDCS | Sham comparator | Device: BrainSTIM Transcranial StimulatorSubjects will receive 20 minutes of sham tDCS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainSTIM Transcranial StimulatorAlso: Cathodal tDCS, Bilateral tDCS, Direct current stimulator, Transcranial stimulatorCathodal stimulation of the auditory cortex with an anode (reference electrode) over the prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA. | Device | Active tDCS |
| BrainSTIM Transcranial StimulatorAlso: Sham stimulation, Direct current stimulator, Transcranial stimulatorSham tDCS sessions will last 20 minutes. | Device | Sham tDCS |
Primary outcome
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.
5 secondary outcomes
Tinnitus Handicap Inventory (THI)
Time frame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention
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
Hospital Anxiety and Depression Scale (HAD)
Time frame: Baseline, 1 month after intervention
Subjective Tinnitus Severity Scale (STSS)
Time frame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention
Clinical Global Impression Scale (CGI)
Time frame: Session 5 (day 5), 1 and 3 months after the last intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Benninger, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BrainSTIM Transcranial Stimulator in people with Tinnitus, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-Bédikian et al., 2010) (time frame: Baseline, 1 month after last intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2012.