rTMS 治疗脑瘫儿童痉挛 - 一项随机对照试验
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
地位
条件
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
注册 (估计的)
阶段
- 不适用
联系人和位置
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
- 姓名:Chai Yin Charlie Fan, MPhil, OTR
- 电话号码:+85222554375
- 邮箱:charliefan@connect.hku.hk
学习地点
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Hong Kong
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Hong Kong、Hong Kong、香港、0000
- 招聘中
- Li Ka Shing Faculty of Medicine
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接触:
- Charlie Fan, MPhil, OTR
- 电话号码:+85222554375
- 邮箱:charliefan@connect.hku.hk
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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
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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
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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
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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 |
|---|---|---|
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Gross motor function measure
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention
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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
|
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Pediatric Quality of Life Cerebral Palsy module
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention
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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
|
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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
|
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Purdue Pegboard Test
大体时间:Baseline, Day 10, 17 of intervention and 2 months post intervention
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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
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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