RecruitingNot Applicable

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

France7 participantsStarted 2021-04-23

Plain-language 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) of the parieto-insular right operculum 3 (OP3) in a cross-over, double study design.

Who can participate

Age range18 Years – 75 Years

SexALL

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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,
✕

What they're measuring

Effectiveness of the treatment using Deep Brain Stimulation (DBS) of the right operculum 3 (OP3).

Timeframe: 2.5 months

Trial details

NCT IDNCT04296097

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Stéphan CHABARDES, MD, PhD

33 (0)4 76 76 93 85 SChabardes@chu-grenoble.fr

View on ClinicalTrials.gov More Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus trials