Beijing Neurosurgical Institute, Beijing, China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test
研究概览
简要总结
The goal of this randomized clinical controlled trial is to learn about whether neuro-navigation repetitive transcranial magnetic stimulation (nrTMS) was useful to accelerate the recovery in patients with SMA syndrome after glioma resection. The main questions aim to answer:
- Question 1: Whether the nrTMS was useful to accelerate the recovery of motor function back to the preoperative status in participants with SMA syndrome after glioma resection.
- Question 2: Whether the nrTMS was useful to improve postoperative motor function in participants with SMA syndrome after glioma resection.
Participants will continue to receive nrTMS treatment or nrTMS sham-treatment for 7 times on the 8th day after glioma resection to determine whether the TMS was helpful for exercise rehabilitation. The investigator will evaluate the effects of nrTMS treatment through the ratio of recovery of motor function and the time that was from the participants suffering SMA syndrome to totally recover the motor function to the status of motor function in pre-operation.
详细描述
This study will use the 8-coil (Magstem, England, No.4150) and sham 8-coil (Magstem, England) The criteria of enrolled patients are： A. Inclusion time: from April 01 2023 to March 31 2025 (including the current month); B. Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital; C. Right-handed, age: 25-55 years old, tumor located in SMA, no previous treatment history of nervous system disease; D. The patient received wake-up surgery and applied direct cortical electrical stimulation during the operation to determine the location of the motor area; E. Postoperative pathology was low grade glioma; F. Can accept nrTMS rehabilitation treatment.
The excluding criteria are:
A. The tumor grows across the midline to the opposite side; B. When collecting rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °; C. The patient did not have SMA syndrome after operation; D. Vulnerable or special groups and protective measures, such as pregnant women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
There are two stimulating colis with the same shape, color and touch. The one is able to stimulate, the other is able to sham-stimulate. All patients are randomly assigned to use one of the two coils for treatment. Except for the designer, all participant, care provider, investigator, and outcomes assessorthey don not know who used which coil to treatment.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital
- •Right-handed, age: 25-55 years old
- •Tumor located in supplementary motor area
- •No previous treatment history of central nervous system disease
- •The patient received awaken craniotomy
- •Pathological diagnosis is low grade glioma
- •Volunteer to accept nrTMS treatment
排除标准
- •The tumor grows across the midline to the opposite side
- •Regarding rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °
- •The patient did not have SMA syndrome after operation
- •Vulnerable or special groups and protective measures, such as pregnant women
结局指标
主要结局
Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test
时间窗: From the day of tumor resection to 3 months after tumor resection
The motor function recovers back to the status in pre-operation. The motor status means that the muscle strength muscle of upper limb that is controlled by lesional hemisphere. Moreover, the recovering back means that the muscle strength achieves at grade 5 (healthy grade).
次要结局
- Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test(From the day of tumor resection to 3 months after tumor resection)
研究者
TAO JIANG
Director, Department of Neurosurgery, Principal Investigator, Clinical Professor
Beijing Neurosurgical Institute