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

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ClinicalTrials.gov Identifier: NCT04296097
Recruitment Status : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
Clinatec, COMMISSARIAT À L'ÉNERGIE ATOMIQUE ET AUX ÉNERGIES ALTERNATIVES (CEA)
Équipe 5 Neuroimagerie et perfusion cérébrale, Grenoble Institut des Neurosciences (GIN)
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus Without Associated Vestibular Pathology Resistant to Therapeutic Failure With or Without Hearing Loss Device: DBS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)
Masking: Double (Participant, Investigator)
Masking Description:

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
Primary Purpose: Treatment
Official Title: Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Deep Brain Stimulation (DBS) activated
Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position ON
Device: DBS
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
Device: DBS
Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)




Primary Outcome Measures :
  1. Effectiveness of the treatment using Deep Brain Stimulation (DBS) of the right operculum 3 (OP3). [ Time Frame: 2.5 months ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    Emergent Adverse events (partial or general epileptic seizures, worsening of tinnitus, surgical complications, ...): 1) post-operative computed tomography (CT); 2) Clinical evaluation.

  2. Evaluation of the subjective effect of stimulation on quality of life. [ Time Frame: 15 months ]
    Scores on the Tinnitus Handicap Inventory (THI) questionnaire [0/100 : higher scores mean worse outcome] at 6 months (early phase) and at 15 months compared to the preoperative THI of the same patient.

  3. Evaluation of the subjective effect of stimulation on anxiety / depression. [ Time Frame: 15 months ]
    Scores on the Hospital Anxiety and Depression Scale (HAD) [0/21 : higher scores mean worse outcome] at 6 months (early phase) and at 15 months compared to preoperative HAD of the same patient.

  4. Changes comparison of the connectivity of OP3 explored by functional Magnetic Resonance Imaging (fMRI) at 1.5 T. [ Time Frame: 15 months ]
    Functional Magnetic Resonance Imaging records (fMRI 1.5 T) performed preoperatively and at 15 months postoperatively.

  5. 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 ]
    Magnetoencephalography (MEG) records 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.

  6. 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 ]
    Local Field Potential (LFP) records on the electrode when the patient perceives tinnitus features 1) intraoperatively 2) before the implantation of the stimulator.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04296097


Contacts
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Contact: Stéphan CHABARDES, MD, PhD 33 (0)4 76 76 93 85 SChabardes@chu-grenoble.fr
Contact: Caroline SANDRE-BALLESTER, PhD 33 (0)4 38 78 28 51 CSandreballester@chu-grenoble.fr

Locations
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France
CLINATEC
Grenoble, France, 38000
Contact: Stephan CHABARDES, MD, PhD    33 (0)4 76 76 93 85    SChabardes@chu-grenoble.fr   
Contact: Caroline SANDRE-BALLESTER, PhD    33 (0)4 38 78 28 51    CSandreballester@chu-grenoble.fr   
Principal Investigator: Eric SEIGNEURET, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Clinatec, COMMISSARIAT À L'ÉNERGIE ATOMIQUE ET AUX ÉNERGIES ALTERNATIVES (CEA)
Équipe 5 Neuroimagerie et perfusion cérébrale, Grenoble Institut des Neurosciences (GIN)

Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04296097    
Other Study ID Numbers: 38RC18.208
2019-A01562-55 ( Other Identifier: ANSM ID RCB )
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
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
Additional relevant MeSH terms:
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Hearing Loss
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms