Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00486577

Purpose

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

Condition	Intervention	Phase
Hearing Disorders Hearing Loss Hyperacusis Tinnitus	Procedure: significant chronic primary auditory cortex stimulation during the first two weeks Procedure: non significant chronic primary auditory cortex stimulation during the first two weeks	Phase II Phase III

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness Tinnitus Toe Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: Experimental	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

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486577

Contacts

Contact: Emmanuel CUNY, MD	(33)556795577	emmanuel.cuny@chu-bordeaux.fr
Contact: René Dauman, MD	(33)556794757	rene.dauman@chu-bordeaux.fr

Locations

France
University Hospital of Bordeaux - Pellegrin	Recruiting
Bordeaux, France, 33 076
Contact: Emmanuel Cuny, MD (33)556795577 emmanuel.cuny@chu-bordeaux.fr
Sub-Investigator: René Dauman, MD

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:

Emmanuel Cuny, MD

University Hospital of Bordeaux

More Information

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	Promo 2005
Study First Received:	June 13, 2007
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00486577
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases

Neurologic Manifestations
Hyperacusis
Hearing Loss
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009