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Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

NCT ID: NCT01944501

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Tinnitus Hearing Loss

Keywords

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tinnitus hearing loss Transcranial magnetic stimulation Transcranial direct current stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Transcranial Magnetic Stimulation

Patients receiving real transcranial magnetic stimulation

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

TMS over the left temporoparietal cortex

Sham TMS

Patients receiving sham transcranial magnetic stimulation

Group Type PLACEBO_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

TMS over the left temporoparietal cortex

Transcranial Direct Current Stimulation

Patients receiving real transcranial direct current stimulation

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type PROCEDURE

TDCS over the left temporoparietal cortex

Sham TDCS

Patients receiving sham transcranial direct current stimulation

Group Type PLACEBO_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type PROCEDURE

TDCS over the left temporoparietal cortex

Interventions

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Transcranial Magnetic Stimulation

TMS over the left temporoparietal cortex

Intervention Type PROCEDURE

Transcranial Direct Current Stimulation

TDCS over the left temporoparietal cortex

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Joaquim Brasil-Neto

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joaquim P Brasil-Neto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Brasilia

Locations

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Universidade de Brasília

Brasília, Federal District, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CFSNCC2013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CFSNCC2013

Identifier Type: -

Identifier Source: org_study_id