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

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ClinicalTrials.gov Identifier: NCT00486577
Recruitment Status : Completed
First Posted : June 14, 2007
Last Update Posted : January 28, 2011
Sponsor:
Information provided by:
University Hospital, Bordeaux

Study Description
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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

Condition or disease Intervention/treatment Phase
Hearing Disorders Hearing Loss Hyperacusis Tinnitus 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 Phase 2 Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus
Study Start Date : June 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 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
Experimental: 2 Procedure: 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


Outcome Measures
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Primary Outcome Measures :
  1. intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486577


Locations
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France
University Hospital of Bordeaux - Pellegrin
Bordeaux, France, 33 076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Emmanuel Cuny, MD University Hospital, Bordeaux
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00486577    
Other Study ID Numbers: Promo 2005
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011
Keywords provided by University Hospital, Bordeaux:
Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Tinnitus
Hearing Disorders
Hyperacusis
 Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases