search
Back to results

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

Primary Purpose

Tinnitus

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Electroencephalogram, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Dayse Souza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm 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.

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

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory
Assesses change in tinnitus from baseline to follow-up periods post interventions

Secondary Outcome Measures

Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
Self assessment of tinnitus loudness and tinnitus distress.
Acuphenometry
Subjective assessment of the frequency, intensity and type of tinnitus.

Full Information

First Posted
January 25, 2017
Last Updated
January 27, 2017
Sponsor
Federal University of Paraíba
search

1. Study Identification

Unique Protocol Identification Number
NCT03036137
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Anticipated)
Primary Completion Date
May 31, 2017 (Anticipated)
Study Completion Date
September 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Electroencephalogram, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
Direct current stimulator; Transcranial stimulator
Intervention Description
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
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Other Intervention Name(s)
Sham stimulation
Intervention Description
Sham tDCS sessions will last 20 minutes
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory
Description
Assesses change in tinnitus from baseline to follow-up periods post interventions
Time Frame
THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
Secondary Outcome Measure Information:
Title
Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
Description
Self assessment of tinnitus loudness and tinnitus distress.
Time Frame
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.
Title
Acuphenometry
Description
Subjective assessment of the frequency, intensity and type of tinnitus.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dayse Souza
Email
dayse.s.s@hotmail.com
Facility Information:
Facility Name
Dayse Souza
City
Joao Pessoa
State/Province
PB
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs