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Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

Primary Purpose

Tinnitus, Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, hearing loss, Transcranial magnetic stimulation, Transcranial direct current stimulation

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade de Brasília

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Transcranial Magnetic Stimulation

Sham TMS

Transcranial Direct Current Stimulation

Sham TDCS

Arm Description

Patients receiving real transcranial magnetic stimulation

Patients receiving sham transcranial magnetic stimulation

Patients receiving real transcranial direct current stimulation

Patients receiving sham transcranial direct current stimulation

Outcomes

Primary Outcome Measures

Change in Tinnitus Handicap Inventory (THI) scores

Secondary Outcome Measures

Change in Visual Analog Scale scores

Full Information

First Posted
September 9, 2013
Last Updated
September 12, 2013
Sponsor
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT01944501
Brief Title
Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss
Official Title
Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Hearing Loss
Keywords
tinnitus, hearing loss, Transcranial magnetic stimulation, Transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
Patients receiving real transcranial magnetic stimulation
Arm Title
Sham TMS
Arm Type
Placebo Comparator
Arm Description
Patients receiving sham transcranial magnetic stimulation
Arm Title
Transcranial Direct Current Stimulation
Arm Type
Active Comparator
Arm Description
Patients receiving real transcranial direct current stimulation
Arm Title
Sham TDCS
Arm Type
Placebo Comparator
Arm Description
Patients receiving sham transcranial direct current stimulation
Intervention Type
Procedure
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
TMS over the left temporoparietal cortex
Intervention Type
Procedure
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
TDCS over the left temporoparietal cortex
Primary Outcome Measure Information:
Title
Change in Tinnitus Handicap Inventory (THI) scores
Time Frame
THI was measured before intervention (baseline) and after 5 daily sessions (day 5)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim P Brasil-Neto, PhD
Organizational Affiliation
University of Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de Brasília
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
70000
Country
Brazil

12. IPD Sharing Statement

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Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

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