Tinnitus Clinical Trial
Official title:
IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED
Verified date | January 2017 |
Source | Federal University of Paraíba |
Contact | Dayse Souza |
dayse.s.s[@]hotmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | September 1, 2017 |
Est. primary completion date | May 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Dayse Souza | Joao Pessoa | PB |
Lead Sponsor | Collaborator |
---|---|
Federal University of Paraíba |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tinnitus Handicap Inventory | Assesses change in tinnitus from baseline to follow-up periods post interventions | THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention. | |
Secondary | Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress | Self assessment of tinnitus loudness and tinnitus 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. | |
Secondary | Acuphenometry | Subjective assessment of the frequency, intensity and type of tinnitus. | 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. |
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