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Severe Permanent Uni or Bilateral Non-pulsatile TinnitusTINNOP3-DBSNCT04296097

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

A study testing DBS in people with Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus and Without Associated Vestibular Pathology, run by University Hospital, Grenoble at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
DBS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteFrance
Study dates
23 Apr 2021to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Vestibular dysfunction (balance disorder),
  • Epilepsy,
  • Intercurrent serious pathology,
  • Brain tumor,
  • Contraindication to surgery or anesthesia,
  • History of cerebral infection with herpesvirus,
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

France1 site, 1 recruiting

  • CLINATEC

    Grenoble, 38000

    Stephan CHABARDES, MD, PhD, 33 (0)4 76 76 93 85, SChabardes@chu-grenoble.fr

    Caroline SANDRE-BALLESTER, PhD, 33 (0)4 38 78 28 51, CSandreballester@chu-grenoble.fr

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Being tested
DBS
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
Medical subject headings
Tinnitus, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DBSDevice

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

Study groups in NCT04296097
Study groupRoleWhat they receive
Deep Brain Stimulation (DBS) activatedExperimentalPatients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position ON
Receives: Device: DBS
Deep Brain Stimulation (DBS) non-activatedOtherPatients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position OFF
Receives: Device: DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2.5 months

Secondary outcomes (6)

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

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

    Measured: 15 months

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

    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.

    Measured: 15 months

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

    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.

    Measured: 15 months

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

    Functional Magnetic Resonance Imaging records (fMRI 1.5 T) performed preoperatively and at 15 months postoperatively.

    Measured: 15 months

  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.

    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.

    Measured: 15 months

  6. Characterization of the Local Field Potential (LFP) recorded and correlations with tinnitus features perceived by the patient, based on their intensity and characteristic.

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

    Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start23 Apr 2021
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
7 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296097
Sponsor's protocol ID
38RC18.208
Other IDs
2019-A01562-55
Acronym
TINNOP3-DBS
Status last verified
Dec 2024
First submitted
24 Feb 2020
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 30414541

Questions about this trial

What is this clinical trial studying?

A study testing DBS in people with Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus and Without Associated Vestibular Pathology, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stéphan CHABARDES, MD, PhD (33 (0)4 76 76 93 85, SChabardes@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of the treatment using Deep Brain Stimulation (DBS) of the right operculum 3 (OP3). (time frame: 2.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04296097, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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