- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036137
Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus
January 27, 2017 updated by: Dayse da Silva Souza, Federal University of Paraíba
IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
54
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dayse Souza
- Email: dayse.s.s@hotmail.com
Study Locations
-
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PB
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Joao Pessoa, PB, Brazil
- Dayse Souza
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
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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.
Other Names:
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SHAM_COMPARATOR: Sham tDCS
Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.
|
Sham tDCS sessions will last 20 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus Handicap Inventory
Time Frame: THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
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Assesses change in tinnitus from baseline to follow-up periods post interventions
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THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scales (VAS) of perceived tinnitus loudness and 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.
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Self assessment of tinnitus loudness and tinnitus distress.
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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
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.
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Subjective assessment of the frequency, intensity and type of tinnitus.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 1, 2017
Primary Completion (ANTICIPATED)
May 31, 2017
Study Completion (ANTICIPATED)
September 1, 2017
Study Registration Dates
First Submitted
January 25, 2017
First Submitted That Met QC Criteria
January 27, 2017
First Posted (ESTIMATE)
January 30, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
January 30, 2017
Last Update Submitted That Met QC Criteria
January 27, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61192416.9.0000.5188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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