Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
研究概览
简要总结
The purpose of this study is to determine whether Repetitive Transcranial Magnetic Stimulation (rTMS) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy.
详细描述
RTMS is a noninvasive technology that can induce changes in brain function that may lead to functional improvement in people with hemiparesis. This is a randomized, double-blinded, sham-controlled rTMS study in conjunction with intensive daily occupational therapy (OT) for 2 weeks to improve motor function in hemiparetic patients. Participants will be followed for at least 12 weeks after rTMS to detect any clinical change. The sham group participants will be offered an open-label active rTMS treatment plus OT after the 12 week assessment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 10 years; < 21 years
- •Hemiparesis
- •Manual Ability Classification System (MACS) level I through IV
- •Provision of written informed consent by the patient and/or guardian, including understanding that insurance may be billed for the occupational therapy
- •Written assent form signed by participants younger than 18 years of age
排除标准
- •Underlying degenerative or metabolic disorder or supervening medical illness
- •Severe depression or other psychiatric disorder
- •Any participant who is pregnant
- •Any contraindication to TMS (i.e., intracranial metal implants, shunts, ports, pacemaker, baclofen pumps)
- •Any changes or addition of neuropsychiatric medications within 1 month of starting the study or during course of the study (if applicable)
- •Any botulinum toxin (Botox, Myobloc) or phenol injection within the last 3 months prior to the study or during the course of the study (if applicable)
- •Any upper extremity surgery within the last 6 months prior to the study or scheduled during the course of the study (if applicable)
结局指标
主要结局
Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
时间窗: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT
次要结局
未报告次要终点