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

Tinnitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03036137
• Other study ID #: 61192416.9.0000.5188
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 25, 2017
• Last updated: January 27, 2017
• Start date: February 1, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2017
• Source: Federal University of Paraíba
• Contact: Dayse Souza
• Email: dayse.s.s[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: September 1, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Transcranial Direct Current Stimulation
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 Transcranial Direct Current Stimulation
Sham tDCS sessions will last 20 minutes

Locations

Country	Name	City	State
Brazil	Dayse Souza	Joao Pessoa	PB

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress	Self assessment of tinnitus loudness and tinnitus 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.
Secondary	Acuphenometry	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.