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

Phase 2

• Conditions: Tinnitus
• Interventions: Device: Sham Transcranial Direct Current Stimulation; Device: Transcranial Direct Current Stimulation

• Registration Number: NCT03036137
• Lead Sponsor: Federal University of Paraíba

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-27
• Last Update Submitted: 2017-01-27
• Study First Posted: 2017-01-30
• Last Update Posted: 2017-01-30
• Study Start: 2017-02-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	Sham Transcranial Direct Current Stimulation	Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.
Active tDCS	Transcranial Direct Current Stimulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dayse Souza; 🇧🇷 Joao Pessoa, PB, Brazil