Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Effectiveness of the treatment using Deep Brain Stimulation (DBS) of the right operculum 3 (OP3).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Crossover study conducted in double blind design :
- one month Deep Brain Stimulation (DBS) ON, 15 days wash out stimulation OFF, and one month Deep Brain Stimulation (DBS) OFF or
- one month Deep Brain Stimulation (DBS) OFF, 15 days wash out stimulation OFF, and one month Deep Brain Stimulation (DBS) ON
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Vestibular dysfunction (balance disorder),
- •Intercurrent serious pathology,
- •Brain tumor,
- •Contraindication to surgery or anesthesia,
- •History of cerebral infection with herpesvirus,
- •With a contraindication to the practice of MRI, MEG, Computerized Tomography (CT) scan,
- •Under anticoagulants and antiaggregants (Anti vitamin K, low molecular weight heparin, aspirin and derivatives, clopidogrel antiplatelet agents and assimilated, new oral anticoagulants (NACO)) for which a therapeutic window can not be opened within 3 months before and after the surgery,
- •Included in another therapeutic protocol,
- •Progressive dementia or psychiatric illness,
- •Presenting a suicidal risk deemed important for less than 3 months (Montgomery and Asberg depression scale (MADRS): suicidality item (item 10) score> 2),
- •Enforced hospitalisation,
- •Pregnant, parturient or breastfeeding, lack of contraception in patients with the capacity to procreate,
- •Subject to a legal protection measure,
- •Deprived of liberty by judicial or administrative decision,
- •Isolated patient without any contact in case of emergency.
结局指标
主要结局
Effectiveness of the treatment using Deep Brain Stimulation (DBS) of the right operculum 3 (OP3).
时间窗: 2.5 months
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.
次要结局
- Evaluation of the subjective effect of stimulation on quality of life.(15 months)
- Incidence of DBS Treatment on Emergent Adverse Events (Tolerance) after surgical intervention and stimulation following the implantation of the DBS medical device.(15 months)
- Evaluation of the subjective effect of stimulation on anxiety / depression.(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.(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.(One week)
- Changes comparison of the connectivity of OP3 explored by functional Magnetic Resonance Imaging (fMRI) at 1.5 T.(15 months)