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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active tDCS

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.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

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.

Sham tDCS

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

Group Type SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation

Intervention Type DEVICE

Sham tDCS sessions will last 20 minutes

Interventions

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Transcranial 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.

Intervention Type DEVICE

Sham Transcranial Direct Current Stimulation

Sham tDCS sessions will last 20 minutes

Intervention Type DEVICE

Other Intervention Names

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Direct current stimulator; Transcranial stimulator Sham stimulation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes