Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus

Federal University of Paraíba

Status and phase: Unknown; Phase 2

Conditions: Tinnitus

Treatments: Device: Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03036137

61192416.9.0000.5188

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

Active tDCS

Active Comparator group

Description:

Subjects will receive 20 minutes of active tDCS for five consecutive days, current of 2 mA, in the temporoparietal left area, and right prefrontal cortex.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham tDCS

Sham Comparator group

Description:

Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.

Treatment:

Device: Sham Transcranial Direct Current Stimulation