Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus (ACOUSCO)

University Hospital of Bordeaux

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hyperacusis; Hearing Disorders; Hearing Loss; Tinnitus

Treatments: Procedure: significant chronic primary auditory cortex stimulation during the first two weeks; Procedure: non significant chronic primary auditory cortex stimulation during the first two weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT00486577

Promo 2005

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups

1

Experimental group

Treatment:

Procedure: significant chronic primary auditory cortex stimulation during the first two weeks

2

Experimental group

Treatment:

Procedure: non significant chronic primary auditory cortex stimulation during the first two weeks