Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus
IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJanuary 30, 2017
January 1, 2017
4 months
January 25, 2017
January 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tinnitus Handicap Inventory
Assesses change in tinnitus from baseline to follow-up periods post interventions
THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
Secondary Outcomes (2)
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.
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.
Study Arms (2)
Active tDCS
ACTIVE COMPARATORSubjects will receive 20 minutes of active tDCS for five consecutive days, current of 2 mA, in the temporoparietal left area, and right prefrontal cortex.
Sham tDCS
SHAM COMPARATORSubjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.
Interventions
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 sessions will last 20 minutes
Eligibility Criteria
You may qualify if:
- Age of at least 18 years;
- Chronic tinnitus for at least 6 months.
- Age-adjusted normal (sensorineural) hearing
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dayse Souza
João Pessoa, Paraíba, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 30, 2017
Study Start
February 1, 2017
Primary Completion
May 31, 2017
Study Completion
September 1, 2017
Last Updated
January 30, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share