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

NCT ID: NCT04296097

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2026-10-31

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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deep Brain Stimulation (DBS) activated

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

Group Type: EXPERIMENTAL

DBS

Intervention Type: DEVICE

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

Deep Brain Stimulation (DBS) non-activated

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

Group Type: OTHER

DBS

Intervention Type: DEVICE

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

Interventions

DBS

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role: collaborator

Équipe 5 Neuroimagerie et perfusion cérébrale, Grenoble Institut des Neurosciences (GIN)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CLINATEC

Grenoble, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Stéphan CHABARDES, MD, PhD

Role: CONTACT

Phone: 33 (0)4 76 76 93 85

Email: SChabardes@chu-grenoble.fr

Caroline SANDRE-BALLESTER, PhD

Role: CONTACT

Phone: 33 (0)4 38 78 28 51

Email: CSandreballester@chu-grenoble.fr

Facility Contacts

Stephan CHABARDES, MD, PhD

Role: primary

Caroline SANDRE-BALLESTER, PhD

Role: backup

Eric SEIGNEURET, MD, PhD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 21484948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22574285 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25503643 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17032710 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30414541 (View on PubMed)

Other Identifiers

2019-A01562-55

Identifier Type: OTHER

Identifier Source: secondary_id

38RC18.208

Identifier Type: -

Identifier Source: org_study_id