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Clinical Trials in France / NCT04296097
Recruiting Not applicable

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

NCT04296097 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-04-23
Last updated
2024-12-16

Condition(s) studied

Severe Permanent Uni or Bilateral Non-pulsatile TinnitusWithout Associated Vestibular PathologyResistant to Therapeutic FailureWith or Without Hearing Loss

Investigational drug(s) / intervention(s)

DBS

DBS: Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CLINATEC Grenoble France Recruiting

More University Hospital, Grenoble trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04296097 on ClinicalTrials.gov ↗ ← All trials in France