Neural Facilitation of Stimulation-assisted Movements in People With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in Corticospinal Tract Excitability After Training
研究概览
简要总结
Spinal cord injury leads to long-lasting paralysis and impairment. Re-enabling movement of paralyzed areas is challenging and more information is needed about neurological recovery. The purpose of this study is to understand the contribution of individual neural tracts to movements facilitated by transcutaneous spinal cord stimulation (SCS).
详细描述
Spinal cord injury leads to long-lasting motor impairment and paralysis that currently is not "curable". Electrical spinal cord stimulation (SCS) is beginning to be used as a neuromodulation technique to re-enable movement of paralyzed areas, however the mechanisms of neurorecovery induced by electrical neuromodulation of the spinal cord remain poorly understood. The goal of this project is to generate evidence-based knowledge of changes in the short-term excitability of corticospinal and reticulospinal neural structures that may mediate immediate improvements in motor function enabled by SCS. The proposed study will: (1) determine which kinds of SCS-facilitated movements are mediated by the corticospinal tract. (2) determine which kinds of SCS-facilitated movements are mediated by the reticulospinal tract. Having a better understanding of the neural mechanisms that are enhanced by SCS can allow the development of therapies that directly target the excitability and plasticity states of these structures towards improved and accelerated recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Healthy volunteers
- •Age between 16-65
- •Healthy individuals with no major conditions of any organ system
排除标准
- •Healthy volunteers
- •Not willing or able to provide consent
- •Any acute or chronic pain condition
- •Any acute or chronic disease of a major organ system
- •Use of analgesics within 24 hours prior to study appointment
- •Use of caffeine with 3 hours of study appointment
- •History of epilepsy
- •Implanted metal
- •Active medical problems
- •Inclusion criteria:
- •Participants with spinal cord injury (SCI)
- •Age between 16-65
- •Traumatic SCI C4-T9 level, complete (ASIA A) or incomplete (ASIA B, C or D)
- •at least 1 year post injury
- •Stable medical condition
- •difficulty independently performing leg movements in routine activities
- •able to follow simple commands
- •able to speak and respond to questions
- •Exclusion criteria:
- •Participants with spinal cord injury (SCI)
- •Not willing or able to provide consent
- •Any acute or chronic pain condition
- •Any acute or chronic disease of a major organ system
- •Use of analgesics within 24 hours prior to study appointment
- •Use of caffeine with 3 hours of study appointment
- •Presence of tremors, spasms and other significant involuntary movements
- •Etiology of SCI other than trauma
- •Concomitant neurologic disease such as traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy)
- •History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc).
- •Severe joint contractures disabling or restricting lower limb movements.
- •Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities
- •Depression, anxiety, or cognitive impairment
- •Deficit of visuo-spatial orientation
- •Sitting tolerance less than 1 hour
- •Severe hearing or visual deficiency
- •Miss more than 3 appointments without notification
- •Unable to comply with any of the procedures in the protocol
- •Botulinum toxin injection in lower extremity muscles in the prior six months
- •Any passive implants (osteosynthesis material, metallic plates or screws) below T
- •Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.)
- •History of alcoholism or another drug abuse
- •Pregnancy (or possible pregnancy)
- •Having an Intrathecal Baclofen Therapy Pump (ITB pump)
- •History of epilepsy
结局指标
主要结局
Changes in Corticospinal Tract Excitability After Training
时间窗: 30 minutes before and 30 minutes into intervention
This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. Data for this arm were not collected due to early study termination.
Reticulospinal Tract Excitability During Different Types of Movements
时间窗: During intervention, *1 Day*.
This primary outcome measures changes in reticulospinal tract excitability (RST) during training as quantified by changes in reaction time after a startling auditory stimulus. RST contrubution was evaluated for dorsiflexion, plantarflexion, hip flexion movements during precision and range of motion control tasks under three conditions: with transcutaneous spinal cord stimulation or without stimulation. All conditions/evaluations were performed in the same session. 30 repetitions were performed per condition during a single session and averaged for each participant. RST is a ratio calculated by = (visual - startle)/(visual - auditory), where: visual represents the reaction time to a visual cue, auditory represents the reaction time to an auditory cue, startle represents the reaction time to a startling cue. A RST ratio value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task. A value equal or lower than 1 would suggest
次要结局
未报告次要终点
研究者
Ismael Seáñez
Assistant Professor of Biomedical Engineering and Neurosurgery
Washington University School of Medicine