Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

Not Applicable

Completed

• Conditions: Tinnitus; Hearing Loss
• Interventions: Procedure: Transcranial Magnetic Stimulation; Procedure: Transcranial Direct Current Stimulation

• Registration Number: NCT01944501
• Lead Sponsor: University of Brasilia

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-09
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial Magnetic Stimulation	Transcranial Magnetic Stimulation	Patients receiving real transcranial magnetic stimulation
Sham TMS	Transcranial Magnetic Stimulation	Patients receiving sham transcranial magnetic stimulation
Transcranial Direct Current Stimulation	Transcranial Direct Current Stimulation	Patients receiving real transcranial direct current stimulation
Sham TDCS	Transcranial Direct Current Stimulation	Patients receiving sham transcranial direct current stimulation

Primary Outcome Measures

Name	Time	Method
Change in Tinnitus Handicap Inventory (THI) scores	THI was measured before intervention (baseline) and after 5 daily sessions (day 5)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidade de Brasília; 🇧🇷 Brasília, Distrito Federal, Brazil