Pilot Study: A Novel Method of Non-Invasive Brain Stimulation (Kilohertz Transcranial Magnetic Perturbation) to Enhance Motor Function in Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Fugl- Meyer Assessment (Upper Extremity)
研究概览
简要总结
Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the feasibility and efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.
详细描述
The goal of this pilot clinical trial is to test the feasibility of a novel first-in-class non-invasive approach to enhance motor function in chronic stroke patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods.
The trial also aims to assess the preliminary effects of kTMP on upper limb motor performance in individuals with chronic stroke. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate both immediate and longer-term changes in motor performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years with stable upper limb motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to recruitment
- •Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50
- •Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function.
排除标准
- •Participants with cognitive impairment (MoCA < 20), language impairment that interferes with their ability to adhere to the protocol or to provide informed consent.
- •Individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression.
- •Contraindications related to non-invasive brain stimulation
研究组 & 干预措施
Active kTMP
Participants receive 8 V/m of active stimulation
干预措施: kTMP (Device)
结局指标
主要结局
Fugl- Meyer Assessment (Upper Extremity)
时间窗: 10 months
A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment. It is graded from 0 (hemiplegia) to 66 for the Upper extremity. Higher scores signifies better motor control, and hence a better outcome.
Fugl- Meyer Assessment (Upper Extremity)
时间窗: 8 weeks
A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment. It is graded from 0 (hemiplegia) to 66 for the Upper extremity. Higher scores signifies better motor control, and hence a better outcome.
次要结局
- Grasp to Lift Time(10 months)
- Range of Joint Motion (ROM)(10 months)
- Action Research Arm Test (ARAT)(10 months)
- Modified Ashworth Scale (MAS)(10 months)
- Trial to Trial Variability (T2TV)(10 months)
- Transport Time(10 months)
- Grasp to Lift Time(8 weeks)
- Transport Time(8 weeks)
- Movement smoothness of Reach-to-Grasp(8 weeks)
- Action Research Arm Test (ARAT)(8 weeks)
- Trial to Trial Variability (T2TV)(8 weeks)
- Range of Joint Motion (ROM)(8 weeks)