NCT01575496

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

August 3, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

April 10, 2012

Last Update Submit

August 1, 2012

Conditions

Tinnitus

Keywords

TinnitusTranscranial direct current stimulationTranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-BĂ©dikian et al., 2010)

    Assesses the change in tinnitus from baseline to 1 month after intervention.

    Baseline, 1 month after last intervention

Secondary Outcomes (5)

  • Tinnitus Handicap Inventory (THI)

    Baseline, session 5 (day 5), 1 and 3 months after the last intervention

  • Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress

    Baseline, before and after each intervention, 1 and 3 months after the last intervention

  • Hospital Anxiety and Depression Scale (HAD)

    Baseline, 1 month after intervention

  • Subjective Tinnitus Severity Scale (STSS)

    Baseline, session 5 (day 5), 1 and 3 months after the last intervention

  • Clinical Global Impression Scale (CGI)

    Session 5 (day 5), 1 and 3 months after the last intervention

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Subjects will receive 20 minutes of active tDCS.

Device: BrainSTIM Transcranial Stimulator

Sham tDCS

SHAM COMPARATOR

Subjects will receive 20 minutes of sham tDCS.

Device: BrainSTIM Transcranial Stimulator

Interventions

BrainSTIM Transcranial StimulatorDEVICE

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.

Also known as: Cathodal tDCS, Bilateral tDCS, Direct current stimulator, Transcranial stimulator
Active tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • David Benninger, MD

    Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Neurophysiology Laboratory

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 11, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2015

Last Updated

August 3, 2012

Record last verified: 2012-08

Locations

CH(1)