此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

rTMS 治疗脑瘫儿童痉挛 - 一项随机对照试验

2026年9月23日 更新者:Winnie Wan Yee Tso (Dr)、The University of Hong Kong

重复经颅磁刺激(rTMS)治疗偏瘫性脑瘫儿童痉挛——一项随机对照试验

This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training.

Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.

研究概览

详细说明

Cerebral palsy is the most common cause of lifelong physical disability in childhood, with an estimated prevalence of 1.5 per 1000 living biths for primary school-aged children. Spasticity is the most common symptoms in children with cerebral palsy, leading to muscle weakness affecting gross motor functions and causing complications such as pain, contracture and subluzation which will lead to inability to perform activity-based training and subsequently lead to further muscle weakness. Standard therapy with regular physiotherapy and occupational therapy are essential but time-consuming and the effects might not last for longer duration. Patients or caregivers decline medications because of side effects drowsiness while other interventions such as intra-thecal baclofen pump, rhizotomy or surgery are invasive.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has the ability to modulate excitation of the motor cortex area of the brain. There were past studies suggesting that using contralesional inhibitory rTMS was safe and feasible for patients with paediatric subcortical stroke and seemed to improve hand function in patients with hemiparesis. However, limited studies have been published on the effects of rTMS on improving spasticity in children with cerebral palsy. Hence, the objective of this study is to use low-frequency rTMS to the contra-lesional hemisphere in children with hemiplegic cerebral palsy to investigate if rTMS follow by intensive limb training would improve spasiticity of these children and whether the improvement can be sustained for a longer time. The underlying mechanisms that lead to the changes clinically will also be investigated by TMS and MRI.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Winnie Wan Yee Tso, MBBS
  • 电话号码:+85222554295
  • 邮箱:wytso@hku.hk

研究联系人备份

学习地点

    • Hong Kong
      • Hong Kong、Hong Kong、香港、0000
        • 招聘中
        • Li Ka Shing Faculty of Medicine
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients aged between 4 years and 18 years
  • Diagnosis of hemiplegia
  • Upper limb spasticity ≥ 1
  • IQ ≥ 50

Exclusion Criteria:

  • Any contra-indications to rTMS
  • Severe spasticity (score of 4 or more in Ashworth scale)
  • Uncontrollable epilepsy
  • History of Botulinum toxin A injection in previous 6 months
  • Upper limb casting in previous 6 months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Interventional rTMS group

The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 1.5 hours of motor training.

1 Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.

假比较器:Sham rTMS group

The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 1.5 hours of motor training.

Sham Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Modified Ashworth Scale
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention

Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone

Baseline, Day 10, 17 of intervention and 2 months post intervention
The range of motion scores
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention

ROM of thumb adduction, wrist dorsal flexion and extension, and elbow dorsal flexion and extension. Patients' range of motion score will be compared to the normative values

Baseline, Day 10, 17 of intervention and 2 months post intervention
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention

The BOT-2 provides a comprehensive overview of fine and gross motor skills in children and young adults within school age-range.

Baseline, Day 10, 17 of intervention and 2 months post intervention

次要结果测量

结果测量
措施说明
大体时间
Gross motor function measure
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention

Changes in motor function. A 4-point Likert scale with higher score indicates better motor function

Baseline, Day 10, 17 of intervention and 2 months post intervention
Pediatric Quality of Life Cerebral Palsy module
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention

Quality of life measurement. Scores range from 0 to 100 with higher score indicate better quality of life.

Baseline, Day 10, 17 of intervention and 2 months post intervention
MRI Brain: fMRI and DKI
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention

Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention

Baseline, Day 10, 17 of intervention and 2 months post intervention
Purdue Pegboard Test
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention

A standardized evaluation tool used to measure gross movements of hands, fingers, and arms, as well as fine fingertip dexterity.

Baseline, Day 10, 17 of intervention and 2 months post intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月13日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2029年12月1日

研究注册日期

首次提交

2023年11月7日

首先提交符合 QC 标准的

2023年11月10日

首次发布 (实际的)

2023年11月13日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅