Deep Brain Stimulation for Severe Tinnitus Relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinatec
  Grenoble, France Recruiting

Study contacts

• Study coordinator: Stéphan CHABARDES, MD, PhD
• Email: SChabardes@chu-grenoble.fr
• Phone: 33 (0)4 76 76 93 85

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.