Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus (ACOUSCO)
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ClinicalTrials.gov Identifier: NCT00486577 |
Recruitment Status :
Completed
First Posted : June 14, 2007
Last Update Posted : January 28, 2011
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Condition or disease | Intervention/treatment | 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 2 Phase 3 |
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 (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

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 |
- intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score [ Time Frame: 6 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486577
France | |
University Hospital of Bordeaux - Pellegrin | |
Bordeaux, France, 33 076 |
Principal Investigator: | Emmanuel Cuny, MD | University Hospital of Bordeaux |
Responsible Party: | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00486577 |
Other Study ID Numbers: |
Promo 2005 |
First Posted: | June 14, 2007 Key Record Dates |
Last Update Posted: | January 28, 2011 |
Last Verified: | January 2011 |
Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging |
Hearing Loss Deafness Tinnitus Hearing Disorders Hyperacusis |
Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |