RecruitingNot ApplicableNCT04296097

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


Sponsor

University Hospital, Grenoble

Enrollment

7 participants

Start Date

Apr 23, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a brain implant (deep brain stimulation device) can reduce severe, constant ringing in the ears (tinnitus) that has not responded to other treatments. The device sends small electrical signals to a specific part of the brain to interrupt the tinnitus signal. **You may be eligible if...** - You are between 18 and 75 years old - You have constant, non-pulsing tinnitus in one or both ears - Your tinnitus is rated 7 or higher on a pain/severity scale of 10 - Your tinnitus severely affects your quality of life (THI score above 76) - Your tinnitus has not improved with other treatments - You have social health insurance coverage **You may NOT be eligible if...** - You have balance or vestibular disorders - You have epilepsy or a brain tumor - You cannot safely undergo surgery or anesthesia - You take blood thinners that cannot be safely stopped around the time of surgery - You are pregnant or breastfeeding - You have progressive dementia or a serious psychiatric illness - You have a contraindication to MRI scans Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDBS

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


Locations(1)

CLINATEC

Grenoble, France

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NCT04296097