Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus

August 1, 2012 updated by: David Benninger, MD, Centre Hospitalier Universitaire Vaudois

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Department of Neurology, Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • Cathodal tDCS
  • Bilateral tDCS
  • Direct current stimulator
  • Transcranial stimulator
Device: BrainSTIM Transcranial Stimulator
Sham tDCS sessions will last 20 minutes.
Other Names:
  • Sham stimulation
  • Direct current stimulator
  • Transcranial stimulator
Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of sham 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.
Other Names:
  • Cathodal tDCS
  • Bilateral tDCS
  • Direct current stimulator
  • Transcranial stimulator
Device: BrainSTIM Transcranial Stimulator
Sham tDCS sessions will last 20 minutes.
Other Names:
  • Sham stimulation
  • Direct current stimulator
  • Transcranial stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month after last intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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)
Time Frame: Baseline, 1 month after intervention
Assesses anxiety and depression.
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
Assesses tinnitus severity.
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
Patient rating of worsening/improvement in condition following interventions.
Session 5 (day 5), 1 and 3 months after the last intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: David Benninger, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Estimate)

August 3, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-12-02-004761

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus

Clinical Trials on BrainSTIM Transcranial Stimulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe