An Innovative Approach to Restoration of Function in Chronic Ischemic Stroke Using a New Wearable Multifocal Brain Stimulator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Changes in Brain Activation
研究概览
简要总结
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
详细描述
This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved.
This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.
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, Investigator, Outcomes Assessor)
盲法说明
Double-blind, only the care provider is aware of active treatment assignment.
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
- •Patients aged 18-80 years;
- •Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --
排除标准
- •History of seizure;
- •Epileptogenic activity (indicative of increased risk of seizures) on EEG;
- •Any active unstable medical condition;
- •Pregnancy;
- •Schizophrenia, bipolar disorder, alcoholism, or substance abuse;
- •Medications which in the investigator's clinical judgment significantly lower the seizure threshold;
- •Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.;
- •Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study.
- •Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study
- •Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination:
- •National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction.
- •Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm.
- •Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm.
- •Any condition that precludes a high quality brain MRI scan.
结局指标
主要结局
Changes in Brain Activation
时间窗: One business day before treatment begins, one business day after treatment ends, up to 5 weeks
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
次要结局
- TUG (Timed Up and Go Test)(One business day before treatment begins, one business day after treatment ends up to 5 weeks)
- National Institutes of Health Stroke Scale (NIHSS)(One business day before treatment begins, one business day after treatment ends up to 5 weeks)
- ARAT (Action Research Arm Test)(One business day before treatment begins, one business day after treatment ends up to 5 weeks)
- Hand Dynamometer(One business day before treatment begins, one business day after treatment ends up to 5 weeks)
- Fugl-Meyer Motor Arm Score(One business day before treatment begins, one business day after treatment ends up to 5 weeks)
- Pinch Dynamometer Score(One business day before treatment begins, one business day after treatment ends up to 5 weeks)
研究者
David Chiu, MD
Principal Investigator/Sponsor-Investigator
The Methodist Hospital Research Institute