Clinical trial NCT03036137: Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tinnitus
Keywords: Tinnitus
Electroencephalogram
Transcranial Direct Current Stimulation
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Tinnitus Handicap Inventory
timeFrame: THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
Secondary outcomes:
measure: Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
timeFrame: 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.
measure: Acuphenometry
timeFrame: 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.
Other outcomes:
Locations:
city: Joao Pessoa
country: Brazil
facility: Dayse Souza
state: PB
Study officials:
References: