Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus

Phase 2

Completed

• Conditions: Hearing Disorders; Hearing Loss; Hyperacusis; Tinnitus
• Interventions: Procedure: non significant chronic primary auditory cortex stimulation during the first two weeks; Procedure: significant chronic primary auditory cortex stimulation during the first two weeks

• Registration Number: NCT00486577
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

The purpose of this study is to determine whether chronic electrical stimulation of the primary auditory cortex is effective in the treatment of chronic, severe and intractable tinnitus

Detailed Description

Severe and chronic tinnitus - the perception of sound in one or both ears or in the head when non-external sound is present - can be disabling and difficult to treat. Physiopathology of tinnitus can be considered as similar to neuropathic pain. Neuropathic and central pain are treated since ten years by chronic electrical motor cortex stimulation. The hypothesis of this study is that it will be possible to treat severe tinnitus by this stimulation as neuropathic pains are treated by motor cortical stimulation.

* Principal Objective : to evaluate the efficacy of chronic electrical stimulation of the auditory cortex for intractable tinnitus

* Secondary Objective : to evaluate the tolerability and the safety of chronic electrical stimulation of the auditory cortex for intractable tinnitus

* Study design : randomized, cross over, double blind, study to evaluate the efficacy of the chronic electrical stimulation versus sham in severe and chronic tinnitus

* Inclusion criteria :

Patient \>18 years of age and \< 70 years of age Permanent and chronic tinnitus during more than 2 years. A score over 19 at the STI (Quality of life index for tinnitus) Unilateral tinnitus

• Exclusion criteria : Deaf person Surgical or anesthetic contraindication History of psychiatric disorder or suicide Epilepsia

• Number of subjects : 10

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-13
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-14
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-27
• Last Update Posted: 2011-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patient > 18 years of age and < 70 years of age
• Permanent and chronic tinnitus during more than 2 years
• A score over 19 at the STI (Quality of life index)

Exclusion Criteria

• Deaf person
• Surgical or anesthetic contraindication
• History of psychiatric disorder or suicide
• Epilepsia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	non significant chronic primary auditory cortex stimulation during the first two weeks	-
1	significant chronic primary auditory cortex stimulation during the first two weeks	-

Primary Outcome Measures

Name	Time	Method
intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score	6 months

Secondary Outcome Measures

Name	Time	Method
Tinnitus Handicap Questionnaire Multiple Activity Scale for Hyperacusis questionnaires for assessment of the patients and treatment outcome of tinnitus hyperacusis and loss of hearing subjective global improvement scale	6 months

Trial Locations

Locations (1)

University Hospital of Bordeaux - Pellegrin; 🇫🇷 Bordeaux, France