Status:
RECRUITING
Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Commissariat A L'energie Atomique
Équipe 5 Neuroimagerie et perfusion cérébrale, Grenoble Institut des Neurosciences (GIN)
Conditions:
Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus
Without Associated Vestibular Pathology
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Detailed 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 in...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04296097
Start Date
April 23 2021
End Date
October 1 2026
Last Update
December 16 2024
Active Locations (1)
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1
CLINATEC
Grenoble, France, 38000