A Brain Centered Neuroengineering Approach for Motor Recovery After Stroke: Combined Repetitive Transcranial Magnetic Stimulation and Brain-Computer Interface Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
研究概览
简要总结
The purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rTMS) and motor-imagery-based brain computer interface (BCI) training is effective for enhancing motor recovery after stroke.
The PI's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rTMS and BCI training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.
详细描述
The goal of the present study is to develop and evaluate a brain based approach to improve motor recovery after stroke, by combining rTMS and BCI training. Treatments will consist of low frequency rTMS applied to the contralesional hemisphere, followed by BCI training to encourage activity within the lesioned hemisphere. The primary objective of this study is to test the main hypothesis above in a stroke patient population. Subjects will also undergo a period of BCI only treatments after completion of the combined rTMS and BCI portion.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years of age
- •Cortical or subcortical stroke with isolated unilateral motor paresis
- •At least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician
- •Impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension
- •Able to ambulate at least 50 feet with minimal stand-by assistance
- •Upper Extremity Fugl Meyer (Fugl-Meyer et al., 1975) score of greater than or equal to 20 out of 66
- •Beck Depression Inventory (Beck et al., 1961) less than or equal to 19 out of 63
- •Mini-mental State Examination score (Folstein et al., 1975) greater than or equal to 24 out of 30
- •Must have an ipsilesional motor-evoked potential (MEP) in response to TMS
- •Must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care
- •Must be able to communicate clearly in English
- •Must be able to provide consent in writing.
排除标准
- •Personal history of epilepsy or seizures within the past 2 years
- •Previous surgical procedure to the spinal cord
- •Any MRI incompatible devices
- •Pregnancy
- •Claustrophobia
- •Breathing disorder
- •Hearing problems or ringing in the ears
- •Bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
- •Cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient
研究组 & 干预措施
Control
Subjects receiving standard-of-care physical therapy only.
Sham rTMS + Real BCI Training
Subjects will receive sham rTMS followed by real BCI training.
干预措施: rTMS (Device)
Sham rTMS + Real BCI Training
Subjects will receive sham rTMS followed by real BCI training.
干预措施: BCI Training (Behavioral)
Real rTMS + Real BCI Training
Subjects will receive real rTMS followed by real BCI training.
干预措施: rTMS (Device)
Real rTMS + Real BCI Training
Subjects will receive real rTMS followed by real BCI training.
干预措施: BCI Training (Behavioral)
结局指标
主要结局
Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI
时间窗: Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)
The MRI and functional MRI will evaluate the extent to which cortical areas are recruited both during rest and during movement related tasks. This is quantified by a laterality index, calculated as the ratio of activations of ipsi- and contra-lesional precentral gyri during a paretic hand tracking task. A LI of -1 corresponds to entirely contralesional activation, while a value of +1 corresponds to entirely ipsilesional activation.
次要结局
- Changes in Hand Motor Function as Measured by the Box and Block Test(Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks))
- Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test(Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks))
- Changes in Inter-hemispheric Inhibition(Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks))