Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04296097

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

Led by University Hospital, Grenoble · Updated on 2024-12-16

7

Participants Needed

1

Research Sites

283 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Grenoble

Lead Sponsor

C

Commissariat A L'energie Atomique

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 75 years old
  • Uni or bilateral permanent non-pulsatile tinnitus without vestibular pathology, with or without hearing loss
  • Severe tinnitus resistant to treatment failure
  • Tinnitus intensity on the Visual Analog Scale (VAS) 2727 7
  • 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
Not Eligible

You will not qualify if you...

  • Vestibular dysfunction (balance disorder)
  • Epilepsy
  • Intercurrent serious pathology
  • Brain tumor
  • Contraindication to surgery or anesthesia
  • History of cerebral infection with herpesvirus
  • Contraindication to MRI, MEG, or CT scan
  • Use of anticoagulants or antiaggregants without a therapeutic window within 3 months before and after surgery
  • Included in another therapeutic protocol
  • Progressive dementia or psychiatric illness
  • Significant suicidal risk within the last 3 months
  • Enforced hospitalisation
  • Pregnant, breastfeeding, parturient, or lack of contraception if able to procreate
  • Subject to legal protection measures
  • Deprived of liberty by judicial or administrative decision
  • Isolated patient without emergency contact

AI-Screening

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Trial Site Locations

Total: 1 location

1

CLINATEC

Grenoble, France, 38000

Actively Recruiting

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Research Team

S

Stéphan CHABARDES, MD, PhD

CONTACT

C

Caroline SANDRE-BALLESTER, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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