Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change from baseline - Fugl-Meyer assessment of the upper limb
研究概览
简要总结
The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke.
Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery.
The aims of the study are:
- to determine the improvements in hand and arm function that result from the combined application of non-invasive spinal stimulation and activity-based rehabilitation. Surface electrodes placed over the skin of the neck will be used for non-invasive electrical stimulation of the spinal cord. Functional task practice will be used for activity-dependent rehabilitation,
- to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis
- •At least six months post-stroke
- •Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit
- •Medically and neurologically stable, as determined by medical history and documented physical examination
- •For women of childbearing potential, a negative over-the-counter pregnancy test at study entry and willingness to practice adequate contraception during the study
- •Ability to attend sessions three times per week
- •Adequate social support to participate in all intervention and baseline, follow-up assessment sessions throughout eight months.
- •Ability to read, comprehend and speak English
排除标准
- •Hemorrhagic stroke
- •History of multiple strokes
- •Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
- •Aphasia or any other deficit in communication that interferes with reasonable study participation
- •Moderate to severe cognitive impairment
- •Presence of neglect (inability to perceive or awareness of, or loss of attention to the weaker half of the body)
- •Severe spasticity in the upper limb
- •Taking baclofen more than 30 mg/day
- •Change in baclofen dose within four weeks before enrollment
- •Receiving benzodiazepines, dantrolene, tizanidine, anticoagulant, or antiepileptic medication
- •Botulinum toxin injection to the upper limb muscles within six months before enrollment
- •Severe joint contractures in the affected hand and arm
- •History of spontaneous seizure that had occurred one month or longer after the stroke
结局指标
主要结局
Change from baseline - Fugl-Meyer assessment of the upper limb
时间窗: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
The clinician-administered a stroke-specific, performance-based impairment scale. It assesses movement function, sensation, joint range of motion, and pain. The score ranges from 0 to 66. Higher scores indicate better outcomes.
Change from baseline - Pinch and grip force
时间窗: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
Measurement of hand strengths using a dynamometry.
Change from baseline - Modified Ashworth Scale
时间窗: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
Clinician-administered test for resistance of a joint to passive movement. This scale grades muscle tone/spasticity. The score ranges from 0 to 4. Higher scores indicate worse outcomes.
Change from baseline - Wolf Motor Function Test
时间窗: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."
Quantifies upper limb motor ability through timed and functional tasks. The score range is 0-75; higher scores denote better function.
次要结局
- Change from baseline - H-reflex test("Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months.")
- Change from baseline - Spinally evoked motor potentials test("Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months.")
- Change from baseline - Action Research Arm Test("Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months.")
- Change from baseline - Box and Blocks Test("Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months.")
- Change from baseline - Stroke Impact Scale("Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months.")
- Change from baseline - Somatosensory evoked potentials test("Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months.")
- Change from baseline - Revised Nottingham Sensory Assessment("Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months.")
- Change from baseline - Short Form-36("Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months.")
- Change from baseline - Patients Global Impression of Change("Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months.")
研究者
Chet Moritz
Associate Professor, Electrical and Computer Engineering, Rehabilitation Medicine
University of Washington