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Sponsored by: |
University Hospital, Bordeaux |
---|---|
Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00486577 |
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 |
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 |
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
|
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.
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
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emmanuel CUNY, MD | (33)556795577 | emmanuel.cuny@chu-bordeaux.fr |
Contact: René Dauman, MD | (33)556794757 | rene.dauman@chu-bordeaux.fr |
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 |
Principal Investigator: | Emmanuel Cuny, MD | University Hospital of Bordeaux |
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 |
Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging |
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases |
Neurologic Manifestations Hyperacusis Hearing Loss Ear Diseases Tinnitus |
Nervous System Diseases |