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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00486577
Other study ID # Promo 2005
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 13, 2007
Last updated January 27, 2011
Start date June 2007
Est. completion date December 2010

Study information

Verified date January 2011
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
France University Hospital of Bordeaux - Pellegrin Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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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