Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04296097, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT04296097
- Record updated
- 16 December 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Between 18 and 75 years old,; Uni or bilateral permanent non-pulsatile tinnitus, without associated vestibular pathology, with or without hearing loss,; Severe tinnitus resistant to treatment failure,; Tinnitus intensity on the Visual Analog Scale (VAS) ≥ 7,; Presenting a quality of life score on the Tinnitus Handicap Inventory (THI) questionnaire> 76 (= grade 5),; Social security affiliates or beneficiaries of such a scheme; Informed and written consent signed by the patient.
Exclusion: Contraindication to surgery or anesthesia,; 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,; Vestibular dysfunction (balance disorder),; Epilepsy,; History of cerebral infection with herpesvirus,; Progressive dementia or psychiatric illness,; Intercurrent serious pathology,; Brain tumor,; With a contraindication to the practice of MRI, MEG, Computerized Tomography (CT) scan,; Included in another therapeutic protocol,; Presenting a suicidal risk deemed important for less than 3 months (Montgomery and Asberg depression scale (MADRS): suicidality item (item 10) score> 2),; Enforced hospitalisation,; Pregnant, parturient or breastfeeding, lack of contraception in patients with the capacity to procreate,; Subject to a legal protection measure,; Deprived of liberty by judicial or administrative decision,; Isolated patient without any contact in case of emergency.