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临床试验 NCT04725019 针对脑瘫目前尚未招募。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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波士顿大学Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation 60
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临床试验NCT04725019是一项针对脑瘫的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2021年8月1日开始，预计招募60名患者。该研究由波士顿大学主导，计划于2026年7月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2021年1月26日。
简要概括
The goal of this study is to test the effects of transcranial direct current stimulation (tDCS) on motor learning and brain plasticity in children with unilateral spastic cerebral palsy (USCP).
官方标题
Enhancing Motor Learning in Children With Cerebral Palsy Using Transcranial Direct-current Stimulation
疾病
脑瘫其他研究标识符
- 5825
NCT编号
实际开始日期
2021-08-01
最近更新发布
2021-01-26
预计完成日期
2026-07-31
计划入组人数
60
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
三盲
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Active tDCS + motor training In this arm, participants will receive 20 minutes of active tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. | active transcranial direct current stimulation Participants will receive 20 min of tDCS over the scalp during 20 min of motor training. 运动训练 Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days. |
实验性Sham tDCS + motor training In this arm, participants will receive 20 minutes of sham tDCS and motor training that involves a high number of repetitions while engaged in child-friendly games. Children receiving sham tDCS will wear the tDCS device but not receive active stimulation. | 运动训练 Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Changes in the Assisting Hand Assessment | Investigators will measure changes in how well the child uses both hands cooperatively for bimanual activities. | Day before intervention begins, compared to day after intervention ends (approximately 1 week) |
Changes in the Box and Blocks test | Investigators will measure changes in the movement speed of the hands. | Day before intervention begins, compared to day after intervention ends (approximately 1 week) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Changes in Motor-evoked Potential assessment | Investigators will measure change in measurements of cortical excitability using transcranial magnetic stimulation (TMS) from baseline to follow-up (1 week). | Day before intervention begins, compared to day after intervention ends (approximately 1 week) |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
6 Years
适龄性别
全部
Children between 6-17 years old who have been diagnosed with cerebral palsy, with the following joint mobility: wrist extension 20º, metacarpophalangeal and proximal interphalangeal joints 10º. Ability to cooperate and follow simple directions.
- Seizure beyond age 2, use of anti-seizure medication, history or family history of epilepsy, cranial metal implants, structural brain lesion, devices that may be affected by tDCS or TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- True positive response on the Transcranial Magnetic Stimulation and MRI Safety Screen
- Current use of medications known to lower the seizure threshold
- Previous episode of unprovoked neurocardiogenic syncope
- Indwelling metal or incompatible medical devices
- Centrally-acting medications including anti-seizure medications
- Evidence of scalp disease or skin abnormalities
- Current medical illness unrelated to CP
- High motor ability in affected arm (i.e. no asymmetry in scores of hand function)
- Severe spasticity
- Lack of asymmetry in hand function
- Orthopedic surgery in affected arm
- Botulinum toxin therapy in either upper extremity during last 6 months, or planned during study period
- Currently receiving intrathecal baclofen
- History of broken arm (either arm) 1 year prior to study enrollment
波士顿大学281 个活跃的临床试验可供探索研究责任方
Claudio, 主要研究者, Assistant Professor, Boston University Charles River Campus
研究中心联系人
联系人: Claudio L Ferre, PhD, (617) 353-7489, [email protected]
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