MedDataX Logo

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

NCT ID: NCT01575496

Last Updated: 2012-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Tinnitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tinnitus Transcranial direct current stimulation Transcranial magnetic stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active tDCS

Subjects will receive 20 minutes of active tDCS.

Group Type ACTIVE_COMPARATOR

BrainSTIM Transcranial Stimulator

Intervention Type DEVICE

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.

Sham tDCS

Subjects will receive 20 minutes of sham tDCS.

Group Type SHAM_COMPARATOR

BrainSTIM Transcranial Stimulator

Intervention Type DEVICE

Sham tDCS sessions will last 20 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

BrainSTIM Transcranial Stimulator

Sham tDCS sessions will last 20 minutes.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cathodal tDCS Bilateral tDCS Direct current stimulator Transcranial stimulator Sham stimulation Direct current stimulator Transcranial stimulator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Benninger, MD

Principal Investigator, Head of Neurophysiology Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Benninger, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Neurology, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIV-12-02-004761

Identifier Type: -

Identifier Source: org_study_id