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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David Benninger, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01575496
First received: April 10, 2012
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Tinnitus
 Device: BrainSTIM Transcranial Stimulator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) for the Treatment of Chronic Subjective Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-Bédikian et al., 2010) [ Time Frame: Baseline, 1 month after last intervention ] [ Designated as safety issue: No ]
    Assesses the change in tinnitus from baseline to 1 month after intervention.


Secondary Outcome Measures:
  • Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self assessment of tinnitus loudness and tinnitus distress.

  • Hospital Anxiety and Depression Scale (HAD) [ Time Frame: Baseline, 1 month after intervention ] [ Designated as safety issue: No ]
    Assesses anxiety and depression.

  • Subjective Tinnitus Severity Scale (STSS) [ Time Frame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention ] [ Designated as safety issue: No ]
    Assesses tinnitus severity.

  • Clinical Global Impression Scale (CGI) [ Time Frame: Session 5 (day 5), 1 and 3 months after the last intervention ] [ Designated as safety issue: No ]
    Patient rating of worsening/improvement in condition following interventions.


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of sham tDCS.
 Device: BrainSTIM Transcranial Stimulator
Sham tDCS sessions will last 20 minutes.
Other Names:
  • Sham stimulation
  • Direct current stimulator
  • Transcranial stimulator

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575496

Locations
Switzerland
Department of Neurology, Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: David Benninger, MD Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided

Responsible Party: David Benninger, MD, Principal Investigator, Head of Neurophysiology Laboratory, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01575496     History of Changes
Other Study ID Numbers: CIV-12-02-004761
Study First Received: April 10, 2012
Last Updated: August 1, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Tinnitus
Transcranial direct current stimulation
Transcranial magnetic stimulation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013