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

NCT04296097 | Recruiting DMC

• 2 other identifiers: 38RC18.2082019-A01562-55
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus; Without Associated Vestibular Pathology; Resistant to Therapeutic Failure; With or Without Hearing Loss

Keywords

Tinnitus; Deep Brain Stimulation (DBS); Right operculum 3 (OP3); Functional Magnetic Resonance Imaging (fMRI); Magnetoencephalography (MEG); Local Field Potential (LFP); Visual Analog Scale (VAS); Tinnitus Handicap Inventory (THI) questionnaire; Hospital Anxiety and Depression Scale (HAD); Cross-over study; Double blind design

Outcome Measures

Primary Outcomes (1)

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

  Difference in intensity of tinnitus Visual Analog Scale (VAS) \[0/10 : higher scores mean better outcome\] between the end and the beginning of each of the two periods of the crossover.

  2.5 months

Secondary Outcomes (6)

• Incidence of DBS Treatment on Emergent Adverse Events (Tolerance) after surgical intervention and stimulation following the implantation of the DBS medical device.

  15 months

• Evaluation of the subjective effect of stimulation on quality of life.

  15 months

• Evaluation of the subjective effect of stimulation on anxiety / depression.

  15 months

• Changes comparison of the connectivity of OP3 explored by functional Magnetic Resonance Imaging (fMRI) at 1.5 T.

  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.

  15 months

Study Arms (2)

Deep Brain Stimulation (DBS) activated

EXPERIMENTAL

Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position ON

Device: DBS

Deep Brain Stimulation (DBS) non-activated

OTHER

Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position OFF

Device: DBS

Interventions

DBS DEVICE

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

Deep Brain Stimulation (DBS) activated; Deep Brain Stimulation (DBS) non-activated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Commissariat A L'energie Atomique: collaborator
• Équipe 5 Neuroimagerie et perfusion cérébrale, Grenoble Institut des Neurosciences (GIN): collaborator

Study Sites (1)

CLINATEC

Grenoble, 38000, France

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Tinnitus; Depression

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

Stéphan CHABARDES, MD, PhD

CONTACT

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

Caroline SANDRE-BALLESTER, PhD

CONTACT

33 (0)4 38 78 28 51; CSandreballester@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Crossover study conducted in double blind design : * one month Deep Brain Stimulation (DBS) ON, 15 days wash out stimulation OFF, and one month Deep Brain Stimulation (DBS) OFF or * one month Deep Brain Stimulation (DBS) OFF, 15 days wash out stimulation OFF, and one month Deep Brain Stimulation (DBS) ON
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 5, 2020
• Study Start: April 23, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

FR (1)