Randomized Controlled Multicenter Trial on the Impact of Presurgical Navigated Transcranial Magnetic Stimulation for Motor Mapping of Rolandic Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 7
- 主要终点
- Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale
研究概览
简要总结
To compare presurgical motor mapping by navigated transcranial magnetic stimulation for surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data into neuronavigation as control.
Primary objective: Permanently new postoperative deficit is lower when the preoperative motor mapping is available to the surgeon
详细描述
Experimental intervention:
presurgical motor mapping by navigated transcranial magnetic stimulation and fusion with intraoperative neuronavigation
Control intervention:
presurgical motor mapping by navigated transcranial magnetic stimulation without access of the surgeon to this data Follow-up per patient: 6 months Duration of intervention per patient: 45 minutes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for resection of a supratentorial tumor within or adjacent to the primary motor cortex
- •preoperative nTMS mapping of the ipsilateral hemisphere
- •implementation of the mapping data into preoperative planning
- •continuous MEP monitoring - informed consent
排除标准
- •no motor eloquent tumor
- •infratentorial tumor
- •no postoperative imaging
- •prognosis lower than 3 months of survival - age <18 years
研究组 & 干预措施
nTMS
presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation
干预措施: nTMS data available for the surgeon (Procedure)
non-nTMS
presurgical motor mapping by nTMS without access of the surgeon to these data
干预措施: nTMS data not available for the surgeon (Procedure)
结局指标
主要结局
Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale
时间窗: 3 months after surgery
deterioration in NIHSS score
次要结局
- change of the approach(1 - 7 days before surgery)
- use of intraoperative motor mapping via MEP(intraoperatively)
- changed indication for surgery(1 - 7 days before surgery)
- duration of intraoperative motor mapping via MEP(intraoperatively)
- extent of resection(intraoperatively)
- size of craniotomy(intraoperatively)
- duration of surgery(intraoperatively)
- use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)(intraoperatively)