Chronic Electrical Stimulation of the Auditory Cortex for Intractable Tinnitus

NCT00486577 | Completed Phase 2 DMC

• 1 other identifier: Promo 2005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Hearing Disorders; Hearing Loss; Hyperacusis; Tinnitus

Keywords

Hearing Disorders, Hearing Loss, Hyperacusis, Tinnitus, chronic cortical stimulation, functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score

  6 months

Secondary Outcomes (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

  6 months

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

significant chronic primary auditory cortex stimulation during the first two weeks PROCEDURE

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

1

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

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

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Deaf person
• Surgical or anesthetic contraindication
• History of psychiatric disorder or suicide
• Epilepsia

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital of Bordeaux - Pellegrin

Bordeaux, Bordeaux, 33 076, France

Location

Related Publications (1)

• 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.

  PMID: 25017670 DERIVED

MeSH Terms

Conditions

Hearing Disorders; Hearing Loss; Hyperacusis; Tinnitus

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Cuny, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 14, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 28, 2011

Record last verified: 2011-01

Locations

FR (1)