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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)
CLINATEC
Grenoble, France
RECRUITINGEffectiveness of the treatment using Deep Brain Stimulation (DBS) of the right operculum 3 (OP3).
Difference in intensity of tinnitus Visual Analog Scale (VAS) \[0/10 : higher scores mean better outcome\] between the end and the beginning of each of the two periods of the crossover.
Time frame: 2.5 months
Incidence of DBS Treatment on Emergent Adverse Events (Tolerance) after surgical intervention and stimulation following the implantation of the DBS medical device.
Emergent Adverse events (partial or general epileptic seizures, worsening of tinnitus, surgical complications, ...): 1) post-operative computed tomography (CT); 2) Clinical evaluation.
Time frame: 15 months
Evaluation of the subjective effect of stimulation on quality of life.
Scores on the Tinnitus Handicap Inventory (THI) questionnaire \[0/100 : higher scores mean worse outcome\] at 6 months (early phase) and at 15 months compared to the preoperative THI of the same patient.
Time frame: 15 months
Evaluation of the subjective effect of stimulation on anxiety / depression.
Scores on the Hospital Anxiety and Depression Scale (HAD) \[0/21 : higher scores mean worse outcome\] at 6 months (early phase) and at 15 months compared to preoperative HAD of the same patient.
Time frame: 15 months
Changes comparison of the connectivity of OP3 explored by functional Magnetic Resonance Imaging (fMRI) at 1.5 T.
Functional Magnetic Resonance Imaging records (fMRI 1.5 T) performed preoperatively and at 15 months postoperatively.
Time frame: 15 months
Connectivities changes of the right OP3 measured by magnetoencephalography (MEG) at baseline 'preoperatively) and the post op (within 1 week) and at long term follow up (15 months) with active stimulation (ON) and inactive (OFF) during MEG recording.
Magnetoencephalography (MEG) records at baseline (preoperatively) and the post op (within 1 week) and at long term follow up (15 months) with active stimulation (ON) and inactive (OFF) during MEG recording.
Time frame: 15 months
Characterization of the Local Field Potential (LFP) recorded and correlations with tinnitus features perceived by the patient, based on their intensity and characteristic.
Local Field Potential (LFP) records on the electrode when the patient perceives tinnitus features 1) intraoperatively 2) before the implantation of the stimulator.
Time frame: One week
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