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

F

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

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

Trial contacts and locations

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Central trial contact

Dayse Souza

Data sourced from clinicaltrials.gov

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