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

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Mar 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Deep Brain Stimulation (DBS) for people who experience severe, permanent tinnitus, which is a ringing or buzzing sound in the ears that doesn't go away. The trial focuses on participants aged 18 to 75 who have either one-sided or both-sided tinnitus that has not improved with other treatments. To qualify, individuals must have a high level of tinnitus severity, as measured on a scale, and a significant impact on their quality of life.

Participants in this study can expect to receive DBS, a procedure that involves implanting a small device in the brain to help reduce the tinnitus symptoms. The trial is currently recruiting, and everyone who joins will be required to give their informed consent, ensuring they understand what the study involves. It's important to note that individuals with certain conditions, such as balance disorders, serious illnesses, or those taking specific medications, will not be eligible to participate. This study could potentially offer new hope for those struggling with debilitating tinnitus.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Between 18 and 75 years old,
• • 2. Uni or bilateral permanent non-pulsatile tinnitus, without associated vestibular pathology, 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 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 weight heparin, aspirin and derivatives, clopidogrel antiplatelet agents and assimilated, new oral anticoagulants (NACO)) for which a therapeutic window can not be opened within 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 and Asberg depression scale (MADRS): suicidality item (item 10) score\> 2),
• • 12. Enforced hospitalisation,
• • 13. Pregnant, parturient or breastfeeding, lack of contraception in patients with the capacity 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.