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RecruitingNot ApplicableNCT04296097

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

Sponsor

University Hospital, Grenoble

Enrollment

7 participants

Start Date

Apr 23, 2021

Study Type

INTERVENTIONAL

Conditions

Severe Permanent Uni or Bilateral Non-pulsatile TinnitusWithout Associated Vestibular PathologyResistant to Therapeutic FailureWith or Without Hearing Loss

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria16

  • 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.

Interventions

DEVICEDBS

Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)

Locations(1)

CLINATEC

Grenoble, France

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NCT04296097