Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS) (TINNOP3-DBS)
Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus, Without Associated Vestibular Pathology, Resistant to Therapeutic Failure
About this trial
This is an interventional treatment trial for Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus focused on measuring Tinnitus, Deep Brain Stimulation (DBS), Right operculum 3 (OP3), Functional Magnetic Resonance Imaging (fMRI), Magnetoencephalography (MEG), Local Field Potential (LFP), Visual Analog Scale (VAS), Tinnitus Handicap Inventory (THI) questionnaire, Hospital Anxiety and Depression Scale (HAD), Cross-over study, Double blind design
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Vestibular dysfunction (balance disorder),
- Epilepsy,
- Intercurrent serious pathology,
- Brain tumor,
- Contraindication to surgery or anesthesia,
- History of cerebral infection with herpesvirus,
- With a contraindication to the practice of MRI, MEG, Computerized Tomography (CT) scan,
- 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,
- Included in another therapeutic protocol,
- Progressive dementia or psychiatric illness,
- 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.
Sites / Locations
- CLINATECRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Deep Brain Stimulation (DBS) activated
Deep Brain Stimulation (DBS) non-activated
Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position ON
Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position OFF