IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Tinnitus
- Sponsor
- Federal University of Paraíba
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Tinnitus Handicap Inventory
- Last Updated
- 9 years ago
Overview
Brief Summary
Relating the electroencephalogram findings of patients with tinnitus before and after a therapeutic modality is still scarce in the literature, especially with neuromodulatory methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n = 18) will be recruited for comparative purposes of brain electrical activity with and without tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale - VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be performed after 1 month of the end of treatment with tDCS.
Investigators
Dayse da Silva Souza
Principal Investigator
Federal University of Paraíba
Eligibility Criteria
Inclusion Criteria
- •Age of at least 18 years;
- •Chronic tinnitus for at least 6 months.
- •Age-adjusted normal (sensorineural) hearing
Exclusion Criteria
- •Pregnancy and/or lactation;
- •Concurrent treatment for tinnitus;
- •Prior exposure to transcranial direct current stimulation (tDCS);
- •History of epilepsy and/or seizures;
- •Electronic implants or metallic objects in body;
- •Skin conditions where electrodes will be applied;
- •Major neurological co-morbidities.
Outcomes
Primary Outcomes
Tinnitus Handicap Inventory
Time Frame: THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
Assesses change in tinnitus from baseline to follow-up periods post interventions
Secondary Outcomes
- Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress(Visual analogue scale of tinnitus wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.)
- Acuphenometry(Acufhenometry wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.)