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临床试验 NCT06128746 针对CP（脑瘫）目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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香港大学重复经颅磁刺激治疗获得性脑损伤后脑瘫/偏瘫儿童痉挛的随机对照试验 20
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临床试验NCT06128746是一项针对CP（脑瘫）的干预性研究试验，目前试验状态为招募中。试验始于2024年1月13日，计划招募20名患者。该研究由香港大学主导，预计于2026年8月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年4月2日。
简要概括
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 sc...
显示更多详细描述
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 act...显示更多
官方标题
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Spasticity in Children With Hemiplegic Cerebral Palsy/ Hemiplegia Due to Acquired Brain Injury - a Randomized Controlled Trial
疾病
CP（脑瘫）其他研究标识符
- rTMSCPHKU
NCT编号
实际开始日期
2024-01-13
最近更新发布
2026-04-02
预计完成日期
2026-08
计划入组人数
20
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
TMS
Cerebral palsy
Spasticity
Cerebral palsy
Spasticity
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Interventional rTMS group The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 30 minutes of intensive limb training. | 重复经颅磁刺激 1 Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training |
模拟对照Sham rTMS group The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 30 minutes of intensive limb training afterwards. | 假重复经颅磁刺激 Sham Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Modified Ashworth Scale | Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone | Day 10, 17 of intervention and 2 months post intervention |
The range of motion scores | 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 | Day 10, 17 of intervention and 2 months post intervention |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Zancolli scale | Severity of forearm alignment. Scores range from 0 to 3 with a higher score indicate worse hand function | Day 10, 17 of intervention and 2 months post intervention |
House functional classification scale | Rating of functional use of the impaired upper limb. Scale consists of nine grades from 0 (does not use) to 8 (full spontaneous use) | Day 10, 17 of intervention and 2 months post intervention |
Gross motor function measure | Changes in motor function. A 4-point Likert scale with higher score indicates better motor function | Day 10, 17 of intervention and 2 months post intervention |
Assisting hand assessment | Test of hand function | Day 10, 17 of intervention and 2 months post intervention |
Pediatric Quality of Life Cerebral Palsy module | Quality of life measurement. Scores range from 0 to 100 with higher score indicate better quality of life. | Day 10, 17 of intervention and 2 months post intervention |
MRI Brain: fMRI and DKI | Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention | Day 10, 17 of intervention and 2 months post intervention |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
7 Years
适龄性别
全部
- Patients aged between 7 years and 18 years
- Diagnosis of cerebral palsy with hemiplegia
- Upper limb spasticity ≥ 1
- IQ ≥ 50
- 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
香港大学335 个活跃的临床试验可供探索研究责任方
Winnie Wan Yee Tso (Dr), 主要研究者, Clinical Associate Professor, The University of Hong Kong
研究中心联系人
联系人: Winnie Wan Yee Tso, MBBS, +85222554295, [email protected]
联系人: Chai Yin Charlie Fan, MPhil, OTR, +85222554375, [email protected]
1 位于 1 个国家/地区的研究中心
Hong Kong
Li Ka Shing Faculty of Medicine, Hong Kong, Hong Kong, 0000, Hong Kong
Charlie Fan, MPhil, OTR, 联系人, +85222554375, [email protected]
招募中