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NCT Number: NCT04296097

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

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.

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Key information

Conditions

Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus Behavior Behavioral Symptoms Depression Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Resistant to Therapeutic Failure Sensation Disorders Signs and Symptoms Tinnitus With or Without Hearing Loss Without Associated Vestibular Pathology

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DBS

Device

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

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline SANDRE-BALLESTER, PhD

CONTACT

[email protected]

33 (0)4 38 78 28 51

Stéphan CHABARDES, MD, PhD

CONTACT

[email protected]

33 (0)4 76 76 93 85

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

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

Registry information

Acronym: TINNOP3-DBS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2020
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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