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Recruiting NCT04296097

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

No phase Interventional Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus Without Associated Vestibular Pathology Resistant to Therapeutic Failure With or Without Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DBS.
Who it may be relevant to
Registry conditions: Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus, Without Associated Vestibular Pathology, Resistant to Therapeutic Failure, With or Without Hearing Loss. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Effectiveness of the treatment using Deep Brain Stimulation (DBS) of the right operculum 3 (OP3). [Time frame: 2.5 months]
Secondary outcome measures (6)
  • Incidence of DBS Treatment on Emergent Adverse Events (Tolerance) after surgical intervention and stimulation following the implantation of the DBS medical device. [Time frame: 15 months]
  • Evaluation of the subjective effect of stimulation on quality of life. [Time frame: 15 months]
  • Evaluation of the subjective effect of stimulation on anxiety / depression. [Time frame: 15 months]
  • Changes comparison of the connectivity of OP3 explored by functional Magnetic Resonance Imaging (fMRI) at 1.5 T. [Time frame: 15 months]
  • Connectivities changes of the right OP3 measured by magnetoencephalography (MEG) at baseline 'preoperatively) and the post op (within 1 week) and at long term follow up (15 months) with active stimulation (ON) and inactive (OFF) during MEG recording. [Time frame: 15 months]
  • Characterization of the Local Field Potential (LFP) recorded and correlations with tinnitus features perceived by the patient, based on their intensity and characteristic. [Time frame: One week]

Eligibility criteria

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,
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 1 center
  • CLINATEC — Grenoble

Publications

  • Job A, Paucod JC, O'Beirne GA, Delon-Martin C. Cortical representation of tympanic membrane movements due to pressure variation: an fMRI study. Hum Brain Mapp. 2011 May;32(5):744-9. doi: 10.1002/hbm.21063. PMID 21484948
  • Job A, Pons Y, Lamalle L, Jaillard A, Buck K, Segebarth C, Delon-Martin C. Abnormal cortical sensorimotor activity during "Target" sound detection in subjects with acute acoustic trauma sequelae: an fMRI study. Brain Behav. 2012 Mar;2(2):187-99. doi: 10.1002/brb3.21. PMID 22574285
  • Job A, Jacob R, Pons Y, Raynal M, Kossowski M, Gauthier J, Lombard B, Delon-Martin C. Specific activation of operculum 3 (OP3) brain region during provoked tinnitus-related phantom auditory perceptions in humans. Brain Struct Funct. 2016 Mar;221(2):913-22. doi: 10.1007/s00429-014-0944-0. Epub 2014 Dec 12. PMID 25503643
  • Eickhoff SB, Grefkes C, Zilles K, Fink GR. The somatotopic organization of cytoarchitectonic areas on the human parietal operculum. Cereb Cortex. 2007 Aug;17(8):1800-11. doi: 10.1093/cercor/bhl090. Epub 2006 Oct 10. PMID 17032710
  • Maliia MD, Donos C, Barborica A, Popa I, Ciurea J, Cinatti S, Mindruta I. Functional mapping and effective connectivity of the human operculum. Cortex. 2018 Dec;109:303-321. doi: 10.1016/j.cortex.2018.08.024. Epub 2018 Sep 10. PMID 30414541

Identifiers

NCT: NCT04296097 · 38RC18.208 · 2019-A01562-55

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗