Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus (ACOUSCO)

January 27, 2011 updated by: University Hospital, Bordeaux
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33 076
        • University Hospital of Bordeaux - Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: significant chronic primary auditory cortex stimulation during the first two weeks
significant chronic primary auditory cortex stimulation during the first two weeks of the follow up than wash out period followed by two weeks of non significant stimulation
Experimental: 2
Procedure: non significant chronic primary auditory cortex stimulation during the first two weeks
non significant stimulation during the first two weeks of the follow up than wash out period followed by two weeks of significant chronic primary auditory cortex stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Emmanuel Cuny, MD, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 13, 2007

First Submitted That Met QC Criteria

June 13, 2007

First Posted (Estimate)

June 14, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Promo 2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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