Optimisation du Ciblage du VIM Pour la Radiochirurgie Dans le Tremblement sévère
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage improvement in tremor in the treated upper limb
研究概览
简要总结
Essential tremor is a common neurological disease, the most severe form of which combines postural and intention tremor, with significant physical, psychological and social repercussions. It is in these most severe forms that surgical lesioning of the ventro-intermediate nucleus of the thalamus (VIM) has been proposed. The VIM and its region of interest are almost impossible to identify directly on imaging (especially MRI), as it is part of the thalamus, which has the same intensity. To identify it, teams use average coordinates from stereotactic atlases (imprecise due to the high inter-individual variability of brain anatomy) or retrospective series of implanted patients. The hypothesis of the present trial is that the VIM-RS-LAT-1.0 algorithm developed by RebrAIn for radiosurgery will enable targeting that is at least as effective as conventional targeting. This is a single-center, controlled study, the primary endpoint of which will be assessed at one year, in a blinded, phase 3, comparative, non-inferiority, randomized study in two parallel groups of patients with severe tremor undergoing radiosurgery. In the control group, VIM will be targeted conventionally, and in the experimental group, VIM will be targeted by the RebrAIn algorithm (VIM-RS-LAT-1.0 model) of radiosurgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
the primary endpoint will be assessed at one year, in a blinded,manner
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced, disabling, drug-resistant essential tremor
- •Patient selected as part of the multidisciplinary concertation meeting on abnormal movements
- •Patient aged 18 to 85
- •Brain MRI showing no anatomical abnormality contraindicating radiosurgical procedure
- •MATTIS ≥ 130
- •Subject affiliated to or benefiting from a social security scheme
- •Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
排除标准
- •Patients with a contraindication to brain MRI (pacemaker, intracerebral metal object, etc.)
- •Pregnant or breast-feeding women
结局指标
主要结局
Percentage improvement in tremor in the treated upper limb
时间窗: between inclusion and one year post-operatively (after radiosurgery)
Assessed on a composite tremor assessment criterion that strictly replicates the endpoint of the prospective study. The percentage will be considered as a continuous variable, between 0 and 100%, and will be assessed blindly by a single practitioner.
次要结局
- The percentage of improvement in quality of life(Between inclusion and one year post-operatively (after radiosurgery))
- Assessment of % change in postural balance(Between inclusion and one year post-operatively (after radiosurgery))
- Assessment of tolerability(At 12 months)
- Assessment of cognitive performance(At one year postradiosurgery)
- Assess lesion location in relation to targeting(12 months after radiosurgery)
- Medico-economic evaluation of automatic targeting compared with conventional targeting(12 months after radiosurgery)
