Clinical trial NCT01575496: Transcranial Direct Current Stimulation (tDCS) for the Treatment of Tinnitus
Official title: Transcranial Direct Current Stimulation (tDCS) for the Treatment of Chronic Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tinnitus
Keywords: Tinnitus
Transcranial direct current stimulation
Transcranial magnetic stimulation
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-Bédikian et al., 2010)
timeFrame: Baseline, 1 month after last intervention
Secondary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention
measure: Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
timeFrame: Baseline, before and after each intervention, 1 and 3 months after the last intervention
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: Baseline, 1 month after intervention
measure: Subjective Tinnitus Severity Scale (STSS)
timeFrame: Baseline, session 5 (day 5), 1 and 3 months after the last intervention
measure: Clinical Global Impression Scale (CGI)
timeFrame: Session 5 (day 5), 1 and 3 months after the last intervention
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Neurology, Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: David Benninger, MD
role: PRINCIPAL_INVESTIGATOR
References: