Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

September 12, 2013 updated by: Joaquim Brasil-Neto, University of Brasilia
This study aimed at trying transcranial magnetic stimulation and transcranial direct current stimulation as potential treatments to decrease tinnitus in patients with significant hearing loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tinnitus is a very common condition and affects approximately 15% of the population, disrupting sleep, emotional balance and social life of the patients. Acoustic deprivation causes hearing loss and is responsible for a cascade of processes that result in the reorganization of the cortex through a synchronization of neuronal activity related to a cortical re-mapping. Consistent with the hypothesis that tinnitus is caused by abnormal activation of the auditory cortex, repetitive transcranial magnetic stimulation (rTMS) can temporarily reduce cortical hyperactivity through direct neuromodulation of the temporal cortex. Furthermore, studies have shown that transcranial direct current stimulation (tDCS) can also suppress tinnitus. Objective: To determine the effectiveness of rTMS and TDCS in the treatment of patients with chronic tinnitus and auditory loss. Methods: We performed an analytical experimental double-blind study using rTMS and tDCS in patients with chronic tinnitus and hearing loss.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70000
        • Universidade de Brasília

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

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic tinnitus
  • hearing loss

Exclusion Criteria:

  • neurological diseases
  • use of drugs affecting the central nervous system
  • evidence of dementia
  • clinical diagnosis of depression

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transcranial Magnetic Stimulation
Patients receiving real transcranial magnetic stimulation
Procedure: Transcranial Magnetic Stimulation
TMS over the left temporoparietal cortex
Placebo Comparator: Sham TMS
Patients receiving sham transcranial magnetic stimulation
Procedure: Transcranial Magnetic Stimulation
TMS over the left temporoparietal cortex
Active Comparator: Transcranial Direct Current Stimulation
Patients receiving real transcranial direct current stimulation
Procedure: Transcranial Direct Current Stimulation
TDCS over the left temporoparietal cortex
Placebo Comparator: Sham TDCS
Patients receiving sham transcranial direct current stimulation
Procedure: Transcranial Direct Current Stimulation
TDCS over the left temporoparietal cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Tinnitus Handicap Inventory (THI) scores
Time Frame: THI was measured before intervention (baseline) and after 5 daily sessions (day 5)
THI was measured before intervention (baseline) and after 5 daily sessions (day 5)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Visual Analog Scale scores
Time Frame: Visual analog scale of tinnitus was recorded at baseline and after daily 5 TMS or TDCS sessions ( day 5)
Visual analog scale of tinnitus was recorded at baseline and after daily 5 TMS or TDCS sessions ( day 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Investigators

  • Principal Investigator: Joaquim P Brasil-Neto, PhD, University of Brasilia

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

March 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFSNCC2013 (Other Grant/Funding Number: Universidade de Brasília)

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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