Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in Torque
研究概览
简要总结
Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.
详细描述
Spinal cord injury (SCI) is a life-altering event that leads to long-lasting motor impairment. Currently, there is no cure for paralysis. Transcutaneous spinal cord stimulation (tSCS) combined with exercise training can restore posture control, voluntary walking, and arm/hand function in people with SCI. However, its low selectivity in activating specific muscles compared to invasive approaches limits the rehabilitation exercises that can be practiced and help with recovery. This project will generate evidence-based knowledge of the neural mechanisms underlying spatial, frequency, and amplitude control of tSCS in generating different types of leg movements. Participants with SCI will perform leg movements using different stimulation parameter configurations in non-invasive tSCS. We will quantify changes in muscle recruitment, torque generation, and pain enabled by the different stimulation parameters. A clear understanding of the mechanisms by which these different parameters in non-invasive tSCS can be used to selectively target different muscle groups will promote the development of personalized therapies that directly target only those muscles that need assistance while respecting individuals' residual motor function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 16 and 65 years.
- •Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
- •American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
- •Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
- •Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
- •Able to provide consent
- •Ability to follow multiple instructions and communicate pain or discomfort
排除标准
- •Progressive spinal lesions, including degenerative disorders of the spinal cord
- •Pregnant, planning to become pregnant, or currently breastfeeding
- •History of cardiopulmonary disease or cardiac symptoms
- •Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
- •Presence of orthopedic conditions that would negatively affect participation in leg exercise
- •History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled
- •Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders
- •Spasms that limit the ability to participate in leg exercise activity
- •Breakdown in skin area that will be in contact with electrodes
研究组 & 干预措施
No stimulation
Participants complete the study motor tasks and assessments without transcutaneous spinal cord stimulation (tSCS).
干预措施: No Stimulation (Other)
Conventional tSCS
Participants complete the same experimental tasks and assessments while receiving conventional, non-invasive transcutaneous spinal cord stimulation (tSCS) using a single cathode and 30 Hz.
干预措施: Conventional tSCS (Device)
Spatiotemporal tSCS
Participants complete the same tasks and assessments while receiving spatiotemporal tSCS in which stimulation parameters are systematically varied across sessions, including electrode location/configuration (spatial control), frequency, and amplitude (temporal/intensity control), to optimize targeted muscle recruitment and voluntary motor output.
干预措施: Spatiotemporal tSCS (Device)
结局指标
主要结局
Changes in Torque
时间窗: 30 minutes
The primary outcome is a measure of changes in voluntary torque production (Nm)
次要结局
- Muscle activation(30 minutes)
- Pain/Nociception(30 minutes)
研究者
Ismael Seáñez
Assistant Professor of Biomedical Engineering and Neurosurgery
Washington University School of Medicine