Clinical trial NCT00486577: Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus
Official title: Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hearing Disorders
Hearing Loss
Hyperacusis
Tinnitus
Keywords: Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2007-06-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Emmanuel Cuny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engelhardt J, Dauman R, Arne P, Allard M, Dauman N, Branchard O, Perez P, Germain C, Caire F, Bonnard D, Cuny E. Effect of chronic cortical stimulation on chronic severe tinnitus: a prospective randomized double-blind cross-over trial and long-term follow up. Brain Stimul. 2014 Sep-Oct;7(5):694-700. doi: 10.1016/j.brs.2014.05.008. Epub 2014 Jun 4.