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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01575496
• Other study ID #: CIV-12-02-004761
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: April 10, 2012
• Last updated: August 1, 2012
• Start date: April 2012

Study information

• Verified date: August 2012
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• BrainSTIM Transcranial Stimulator
Sham tDCS sessions will last 20 minutes.

Locations

Country	Name	City	State
Switzerland	Department of Neurology, Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory (THI; Newman, Jacobson, & Spitzer, 1996; French version: Ghulyan-Bédikian et al., 2010)	Assesses the change in tinnitus from baseline to 1 month after intervention.	Baseline, 1 month after last intervention	No
Secondary	Tinnitus Handicap Inventory (THI)	Assesses change in tinnitus from baseline to follow-up periods post interventions.	Baseline, session 5 (day 5), 1 and 3 months after the last intervention	No
Secondary	Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress	Self assessment of tinnitus loudness and tinnitus distress.	Baseline, before and after each intervention, 1 and 3 months after the last intervention	No
Secondary	Hospital Anxiety and Depression Scale (HAD)	Assesses anxiety and depression.	Baseline, 1 month after intervention	No
Secondary	Subjective Tinnitus Severity Scale (STSS)	Assesses tinnitus severity.	Baseline, session 5 (day 5), 1 and 3 months after the last intervention	No
Secondary	Clinical Global Impression Scale (CGI)	Patient rating of worsening/improvement in condition following interventions.	Session 5 (day 5), 1 and 3 months after the last intervention	No