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

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: With or Without Hearing Loss; Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus; Without Associated Vestibular Pathology; Resistant to Therapeutic Failure

Treatments: Device: DBS

Study type: Interventional

Funder types: Other

Identifiers

NCT04296097

2019-A01562-55 (Other Identifier)

38RC18.208

Details and patient eligibility

About

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.

Full 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 innovative therapeutic options. Current management is essentially based on psychological therapy and / or prosthetic, to improve for hearing loss that can be frequently associated. In fact, the main objective is habituation for these patients, but when the tinnitus is too intense, it is impossible. Three recent publications in functional magnetic resonance imaging (fMRI) have reported a novel physiopathological hypothesis to explain the appearance of subjective tinnitus. They highlight the prominent role of the right operculum 3 (OP3), a deep opercular region (parieto-insular junction) in the emergence of this symptom. The investigators hypothesize that inhibition of this region using high frequency stimulation could, significantly improve the intensity of the symptom and consequently their quality of life in this selected population.

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

7 participants in 2 patient groups

Deep Brain Stimulation (DBS) activated

Experimental group

Description:

Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position ON

Treatment:

Device: DBS

Deep Brain Stimulation (DBS) non-activated

Other group

Description:

Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position OFF

Treatment:

Device: DBS