Hearing Loss Clinical Trial
Official 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
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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