Linac FRACtionated Radiosurgical THALamotomy in Tremors : a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Treatment toxicity
研究概览
简要总结
Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. In addition, fitting the invasive frame and the need to travel to GammKnife centers often limit access to treatment in this population of elderly patients.
Linear accelerators have greatly improved their precision, now reaching that of GammaKnife. A possible alternative is therefore to treat patients on linear accelerators, without an invasive frame.
The objective of the FRACTHAL study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator.
The main hypothesis of the FRACTHAL study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with disabling essential tremor, dystonic and / or parkinsonian in one or more limbs superiors ;
- •patient contraindicated or refusing deep brain stimulation ;
- •patient ≥ 18 years old,
- •women of childbearing potential must take effective contraception ;
- •signature of informed consent ; p- atients who benefited from contralateral thalami c stimulation can be included in the study
排除标准
- •brain irradiation history ;
- •contraindication or inability to perform injected MRI ;
- •life expectancy <12 months ;
- •claustrophobic patient who cannot stand the radiotherapy mask ;
- •abnormal anatomy of the thalamic region ;
- •treatment with a trial drug within 30 days of entering the study ;
- •presence of medical, psychological, social or geographic factors likely to modify the patient's compliance with the protocol under study or the monitoring or signing of the consent
研究组 & 干预措施
Radiosurgical thalamotomy on GammaKnife
干预措施: Radiosurgical thalamotomy on GammaKnife (Radiation)
结局指标
主要结局
Treatment toxicity
时间窗: 12 months
The treatment will be considered toxic in the event of the appearance, within 12 months after treatment, of non-regressive toxicity of grade\> 1 according to the NCI-CTCAE V5.0 scale (symptomatic neurological deficit interfering with daily activities), and that this deficit is related to the treatment.
次要结局
- Treatment accuracy(At 6 and 12 months)
- Tremor improvement(At 3, 6 and 12 months)