Clinical Research Protocol on Accelerating Motor Rehabilitation in Postoperative Motor-Deficient Glioma Patients Using nrTMS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Muscle strength of the affected limb
研究概览
简要总结
Project Name Clinical Research Protocol on Accelerating Motor Rehabilitation in Postoperative Motor-Deficient Glioma Patients Using nrTMS
Research Objectives
- Investigate the relationship between motor rehabilitation and changes in motor functional networks after nrTMS therapy, and confirm the contralateral hand motor area as an effective rehabilitation target.
- Validate the efficacy of high-frequency nrTMS stimulation in rehabilitating motor deficits in glioma patients.
Study Design > A randomized, double-blind, sham-controlled clinical trial. Eligible postoperative glioma patients with motor dysfunction will be randomized into nrTMS treatment or sham groups. High-frequency nrTMS or sham stimulation targeting the contralateral hand motor area will be administered for 7 consecutive days. Fugl-Meyer Assessment (FMA) scores and muscle strength of the affected limb will be evaluated to determine the superiority of nrTMS over sham stimulation.
Total Cases The study comprises two parts, each enrolling 43 patients.
Case Selection Inclusion Criteria:
A. Right-handed; B. Age: 25-65 years; C. No prior neurological disease history; D. Awake craniotomy with intraoperative direct cortical stimulation or MEP mapping for motor area localization; E. Postoperative pathology confirms newly diagnosed glioma; F. Willing to undergo nrTMS therapy; G. Persistent motor dysfunction (muscle strength/FMA score not restored to preoperative levels) at postoperative day 7.
Exclusion Criteria:
A. Tumor crossing midline to the contralateral hemisphere; B. Head motion >1 mm or rotation >1° during rs-fMRI acquisition; C. Absence of postoperative motor or speech dysfunction; D. Vulnerable populations (e.g., pregnant women). Treatment Protocol High-frequency nrTMS stimulation targeting the contralateral hand motor area (thumb region).
Efficacy Evaluation Primary Outcome: Muscle strength recovery rate of the affected limb.
Secondary Outcome: FMA score recovery rate. Safety Evaluation: Pre- and post-treatment MRI to monitor intracranial changes. Statistical Methods (1) Randomization into nrTMS and sham groups. (2) Baseline comparisons using t-tests and chi-square tests. (3) Longitudinal analysis of muscle strength (chi-square) and FMA scores (t-tests) at key timepoints: preoperative, pretreatment, post-treatment, 1/2/3 months postoperatively.
详细描述
Research Objectives:
Investigate the relationship between motor rehabilitation and changes in motor functional networks after nrTMS therapy, and confirm the contralateral hand motor area as an effective rehabilitation target.
Validate the efficacy of high-frequency nrTMS stimulation in rehabilitating motor deficits in glioma patients.
Study Design: A randomized, double-blind, sham-controlled clinical trial. Eligible postoperative glioma patients with motor dysfunction will be randomized into nrTMS treatment or sham groups. High-frequency nrTMS or sham stimulation targeting the contralateral hand motor area will be administered for 7 consecutive days. Fugl-Meyer Assessment (FMA) scores and muscle strength of the affected limb will be evaluated to determine the superiority of nrTMS over sham stimulation.
Total Cases: The study comprises two parts, each enrolling 43 patients.
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
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Right-handed.
- •Age between 25 and 65 years old.
- •No history of neurological disease treatment before surgery.
- •Underwent awake surgery with intraoperative direct cortical stimulation or motor evoked potential (MEP) mapping to identify the motor functional area.
- •Postoperative pathology confirmed as newly diagnosed glioma.
- •Eligible for navigated repetitive transcranial magnetic stimulation (nrTMS) rehabilitation treatment.
- •Persistent motor dysfunction (muscle strength or Fugl-Meyer Assessment (FMA) scores not returned to preoperative levels) at 7 days postoperatively.
- •Signed informed consent.
排除标准
- •Tumor crossing the midline to the contralateral hemisphere.
- •Excessive head motion (>1 mm translation or >1° rotation) during resting-state functional MRI (rs-fMRI) data acquisition.
- •Absence of postoperative motor or language motor deficits.
- •Vulnerable populations (e.g., pregnant women).
结局指标
主要结局
Muscle strength of the affected limb
时间窗: muscle strength of the affected limb have returned to preoperative levels at pre-treatment, post-treatment, 1 month postoperative, 2 months postoperative, and 3 months postoperative.
Motor function recovery is defined as the affected limb's muscle strength returning to preoperative levels.
次要结局
- Rate of Fugl-Meyer Assessment (FMA) Score Recovery for the Affected Upper Limb(Assessed at pre-treatment (postoperative day 7), post-treatment (after 7 days of intervention), 1 month, 2 months, and 3 months postoperatively.)