Deep Brain Stimulation for Severe Tinnitus Relief

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

This study is testing if deep brain stimulation can help people with severe tinnitus feel better when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Grenoble (Academic / other)
• Locations: 1 site (Grenoble)
• Trial ID: NCT04296097 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the effectiveness of Deep Brain Stimulation (DBS) targeting the right operculum 3 (OP3) in patients suffering from severe, permanent, non-pulsatile tinnitus that has not responded to other treatments. The study employs a cross-over, double-blind design to assess the impact of high-frequency stimulation on tinnitus intensity and quality of life. The rationale is based on recent findings that suggest the OP3 region plays a significant role in the perception of tinnitus, and inhibiting this area may alleviate symptoms. Participants will undergo assessments using functional imaging techniques to monitor changes in brain activity related to tinnitus.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with severe, permanent non-pulsatile tinnitus that is resistant to previous treatments.

Not a fit: Patients with vestibular dysfunction, epilepsy, or other serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce tinnitus severity and improve the quality of life for patients suffering from this debilitating condition.

How similar studies have performed: While this approach is innovative, recent studies have indicated the potential of targeting the OP3 region for tinnitus treatment, suggesting a promising avenue for further exploration.

Eligibility criteria

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.

Where this trial is running

Grenoble

• Clinatec — Grenoble, France (Recruiting)

Study contacts

• Study coordinator: Stéphan CHABARDES, MD, PhD

Conditions Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus; Without Associated Vestibular Pathology; Resistant to Therapeutic Failure; With or Without Hearing Loss; Tinnitus; Deep Brain Stimulation; Right operculum 3; Functional Magnetic Resonance Imaging