Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)

Last updated: December 10, 2024
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

DBS

Clinical Study ID

NCT04296097
38RC18.208
2019-A01562-55
  • Ages 18-75
  • All Genders

Study Summary

This pilot study aims at evaluating the effectiveness of the treatment of unilateral or bilateral, non-pulsatile, disabling, tinnitus, without vestibular dysfunction, using Deep Brain Stimulation (DBS) of the parieto-insular right operculum 3 (OP3) in a cross-over, double study design.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Between 18 and 75 years old,

  2. Uni or bilateral permanent non-pulsatile tinnitus, without associated vestibularpathology, with or without hearing loss,

  3. Severe tinnitus resistant to treatment failure,

  4. Tinnitus intensity on the Visual Analog Scale (VAS) ≥ 7,

  5. Presenting a quality of life score on the Tinnitus Handicap Inventory (THI)questionnaire> 76 (= grade 5),

  6. Social security affiliates or beneficiaries of such a scheme

  7. Informed and written consent signed by the patient.

Exclusion

Exclusion Criteria:

  1. Vestibular dysfunction (balance disorder),

  2. Epilepsy,

  3. Intercurrent serious pathology,

  4. Brain tumor,

  5. Contraindication to surgery or anesthesia,

  6. History of cerebral infection with herpesvirus,

  7. With a contraindication to the practice of MRI, MEG, Computerized Tomography (CT)scan,

  8. Under anticoagulants and antiaggregants (Anti vitamin K, low molecular weightheparin, aspirin and derivatives, clopidogrel antiplatelet agents and assimilated,new oral anticoagulants (NACO)) for which a therapeutic window can not be openedwithin 3 months before and after the surgery,

  9. Included in another therapeutic protocol,

  10. Progressive dementia or psychiatric illness,

  11. Presenting a suicidal risk deemed important for less than 3 months (Montgomery andAsberg depression scale (MADRS): suicidality item (item 10) score> 2),

  12. Enforced hospitalisation,

  13. Pregnant, parturient or breastfeeding, lack of contraception in patients with thecapacity to procreate,

  14. Subject to a legal protection measure,

  15. Deprived of liberty by judicial or administrative decision,

  16. Isolated patient without any contact in case of emergency.

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: DBS
Phase:
Study Start date:
April 23, 2021
Estimated Completion Date:
October 31, 2026

Study Description

Subjective, non-pulsatile, permanent, severe, tinnitus, refractory to all treatment are very disabling. They can lead to serious depression and suicidal behavior, which justifies the development of innovative therapeutic options. Current management is essentially based on psychological therapy and / or prosthetic, to improve for hearing loss that can be frequently associated. In fact, the main objective is habituation for these patients, but when the tinnitus is too intense, it is impossible. Three recent publications in functional magnetic resonance imaging (fMRI) have reported a novel physiopathological hypothesis to explain the appearance of subjective tinnitus. They highlight the prominent role of the right operculum 3 (OP3), a deep opercular region (parieto-insular junction) in the emergence of this symptom. The investigators hypothesize that inhibition of this region using high frequency stimulation could, significantly improve the intensity of the symptom and consequently their quality of life in this selected population.

Connect with a study center

  • CLINATEC

    Grenoble, 38000
    France

    Active - Recruiting

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