Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus
Conditions
Keywords
Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging
Brief summary
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
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
Interventions
PROCEDUREsignificant 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
PROCEDUREnon 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
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed