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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CLINATEC
RECRUITING
Grenoble
Contact Information
Primary
Stéphan CHABARDES, MD, PhD
SChabardes@chu-grenoble.fr
33 (0)4 76 76 93 85
Backup
Caroline SANDRE-BALLESTER, PhD
CSandreballester@chu-grenoble.fr
33 (0)4 38 78 28 51
Time Frame
Start Date: 2021-04-23
Estimated Completion Date: 2026-10
Participants
Target number of participants: 7
Treatments
Experimental: Deep Brain Stimulation (DBS) activated
Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position ON
Other: Deep Brain Stimulation (DBS) non-activated
Patients with severe permanent non-pulsatile tinnitus treated by Deep Brain Stimulation (DBS) in position OFF
Related Therapeutic Areas
Sponsors
Collaborators: Équipe 5 Neuroimagerie et perfusion cérébrale, Grenoble Institut des Neurosciences (GIN), Commissariat A L'energie Atomique
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov