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临床试验/NCT01284699
NCT01284699已完成不适用

Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson's Disease Fulfilling Inclusion Criteria for STN Deep Brain Stimulation and Presenting With a Contraindication to Intracerebral Electrode Implantation.

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Evaluation of the safety and efficacy

研究概览

简要总结

The goal of our trial is to evaluate the tolerance and efficacy of the STN radiosurgery in Parkinsonian patients presenting with the inclusion criteria for the STN stimulation but presenting also with clear contraindications to the implantation of the deep brain electrodes.

详细描述

Subthalamic nucleus (SNT) deep brain stimulation (DBS) is the reference treatment for severe drug resistant Parkinson's disease, responsible to dopaminergic therapy, to the state of complication. The efficacy of this therapeutic approach has transformed the functional prognosis of these patients. Unfortunately, those of the patients presenting with contraindications for anaesthesia or electrode implantation are excluded of these therapeutic hope.

Gamma Knife radiosurgery is a neurosurgical procedure going to operate in the brain of the patients without opening the skull without infection or bleeding risk.

Gamma Knife radiosurgical treatment will be done in two separate times (GK1 and GK2). Treatment of the second side (GK2) will be done at least 12 months after the treatment of the first side (GK1), in the same methodology as the first treatment. The major risk of onset of acute ballism although low is planned to be managed by the standard protocol by the recruiting team involved in the trial.

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
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients presenting with contraindications for anaesthesia or electrode implantation

排除标准

  • contraindications for a surgical treatment
  • Pregnant or breast-feeding women

结局指标

主要结局

Evaluation of the safety and efficacy

时间窗: 48 months

Feasibility of this step is mandatory on the organization of a true randomized comparative trial witch should bring a higher lever of evidence, but in the present state immature from ethical point of view.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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