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New treatment option for Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus
Official title Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)
ClinicalTrials.gov ID: NCT04296097
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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),
You likely can't join if
- Vestibular dysfunction (balance disorder),
- Epilepsy,
- Intercurrent serious pathology,
- Brain tumor,
- Contraindication to surgery or anesthesia,
- History of cerebral infection with herpesvirus,
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.