Tinnitus
Conditions
Keywords
Tinnitus, Electroencephalogram, Transcranial Direct Current Stimulation
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.
Interventions
DEVICETranscranial Direct Current Stimulation
Anodal stimulation of the temporoparietal left area with an cathode over the right dorsolateral prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.
DEVICESham Transcranial Direct Current Stimulation
Sham tDCS sessions will last 20 minutes
Sponsors
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Handicap Inventory | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Self assessment of tinnitus loudness and tinnitus distress. |
| 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. | Subjective assessment of the frequency, intensity and type of tinnitus. |
Countries
Brazil
Contacts
Primary ContactDayse Souza
Outcome results
None listed