NCT04296097

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus
• Without Associated Vestibular Pathology
• Resistant to Therapeutic Failure
• With or Without Hearing Loss

Interventions

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

Timeline

• Start date: 2021-04-23
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2020-03-05
• Last updated: 2024-12-16

Locations

1 site across 1 country: France