Deep Brain Stimulation and Frameless Stereotactic Radiosurgery in the Treatment of Drug Resistant Invalidating Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Tremor control (improvement in FTMTRS and/or UPDRS motor)
研究概览
简要总结
Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually achieved using stereotactic surgical procedures.
Radiosurgery of invisible targets to treat movement disorders and intractable pain are still the domain of frame-based procedures, due to the need of a solid reference system registered to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of stereotactic atlases.
In this study we want to utilize a mathematical method that uses atlas-derived stereotactic coordinates to perform frameless images-guided radiosurgery of such functional targets Particularly the aim of the present study is to investigate both the efficacy and the safety of the methodology to treat upper limb and hand tremor in elderly or in patients which are not ot susceptible of surgical procedures. For these reasons a dose escalation prospective trial have been designed.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients affected by severe upper limb tremor refractory to medical therapy and who are candidate for a deep brain stimulation (DBS) procedure.
- •Age: ≥ 18 years old
- •Refusal of DBS procedure
- •Written consent
排除标准
- •Pregnancy
- •Allergy to contrast medium
- •DBS procedure susceptibility, if not refused
研究组 & 干预措施
Radiosurgical thalamotomy
干预措施: Radiosurgical thalamotomy (Radiation)
结局指标
主要结局
Tremor control (improvement in FTMTRS and/or UPDRS motor)
时间窗: 2 years
Tremor control (improvement in Fahn Tolosa Marin Tremor Rating Scale, FTMTRS, and/or Unified Parkinson's Disease Rating Scale, UPDRS, motor)
次要结局
- Targeting methodology validation (the lesions position, if present, will be compared to the treatment plan target position, deviations will be registered).(2 years)
- The treatment safety will be evaluated. Toxicity will be registered according to NCI-CTCAE v3.(2 years)
