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

Vaud University Hospital Center

Status and phase

Unknown

Phase 2

Conditions

Tinnitus

Treatments

Device: BrainSTIM Transcranial Stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT01575496

CIV-12-02-004761

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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