Hearing Loss Clinical Trial
— ACOUSCOOfficial title:
Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus
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
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Bordeaux - Pellegrin | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score | 6 months | No | |
Secondary | 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 | No |
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