Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

Hearing Loss Clinical Trial

Official title:

Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944501
• Other study ID #: CFSNCC2013
• Secondary ID: CFSNCC2013
• Status: Completed
• Phase: N/A
• First received: September 9, 2013
• Last updated: September 12, 2013
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Tinnitus

Intervention

Procedure:
• Transcranial Magnetic Stimulation
TMS over the left temporoparietal cortex
• Transcranial Direct Current Stimulation
TDCS over the left temporoparietal cortex

Locations

Country	Name	City	State
Brazil	Universidade de Brasília	Brasília	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tinnitus Handicap Inventory (THI) scores		THI was measured before intervention (baseline) and after 5 daily sessions (day 5)	No
Secondary	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)	No