Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Six-Minute Walk Test
研究概览
简要总结
Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date.
This study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with physical therapy for improving locomotion in people with anatomically incomplete tetraplegia and paraplegia.
This experiment design consists of testing walking function with and without transcutaneous spinal cord stimulation. A two to four-phase intervention program will include physical therapy and spinal cord stimulation with physical therapy. The length of any intervention phase, and number of measurements performed during that phase, will be determined by multiple factors, including participants' health condition, availability, and response to intervention. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions.
The intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of intervention. Physical therapy will include functional training (e.g., walking training) and strength training. Each spinal cord stimulation with physical therapy intervention block can use transcutaneous lumbosacral stimulation or cervical and lumbosacral stimulation. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal cord stimulation and intensive physical therapy may be evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has spinal cord injury (T12 or higher level) of at least 1-year duration
- •Is between 21 and 70 years of age
- •Has difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing)
- •Has stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities
- •Is capable of performing simple cued motor tasks
- •Has ability to attend up to 5 sessions per week physical therapy sessions and testing activities
- •Has adequate social support to be able to participate in training and assessment sessions, up to 5 sessions per week, for the duration of up to 11 months within the study period
- •Is volunteering to be involved in this study
- •Cleared for gait training by the primary physician of the subject
- •Has the ability to read and speak English
排除标准
- •Has autoimmune etiology of spinal cord dysfunction/injury
- •Has history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.
- •Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- •Has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- •Has significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
- •Has active cancer
- •Has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- •Has unhealed fracture, contracture, pressure sore, urinary tract infection, or other illnesses that might interfere with lower extremity rehabilitation or testing activities
- •Has any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
- •is pregnant
- •is dependent on ventilation support
- •Has implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc)
- •Has depression or anxiety based on the Center for Epidemiologic Studies Depression Scale (CESD) (score >16/60) and General Anxiety Disorder-7 item Questionnaire (score >9/21), respectively
- •Has alcohol and/or drug abuse
- •Has cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ) (score >2/10)
- •is unable to read and/or comprehend the consent form
- •is unable to understand the instructions given as part of the study
- •Has established osteoporosis and taking medication for osteoporosis treatment
- •Has bone mineral density T scores ≤ -3.5 or Z scores ≤ -2.5 in the anteroposterior lumbar spine and/or proximal femur measured by a DEXA scan for subjects weight bearing and ambulating outside of a body-weight supporting exoskeleton (if participants are clear for other criteria and have not been examined by Dual Energy Xray Absorptiometry (DEXA) at the screening, we will ask participants to undergo DEXA to reveal any risk of weight bearing activity)
- •Has low-energy fracture history before or after spinal cord injury
- •History of orthopedic surgery in lower extremities that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, arthrodesis, etc.)
- •fixed lower extremity joint contractures
- •is taller than 80 inches and/or more than 350 pounds body weights, due to the limitation of the experimental equipment such as the body weight support system
- •lacks the ability to fully comprehend and/or perform study procedures in the investigator's opinion/judgement
- •has history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
- •has malabrosption syndrome, primary hyperthyroidism, and/or hypogonadism
- •has a history of seizures
- •has chronic headaches or migraines
- •has deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators
研究组 & 干预措施
Transcutaneous spinal stimulation & Physical therapy
Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions
干预措施: Transcutaneous spinal stimulation (Device)
Transcutaneous spinal stimulation & Physical therapy
Transcutaneous electrical stimulation combined with physical therapy that targets rehabilitation of walking and standing functions
干预措施: Physical Therapy (Other)
Physical therapy only
Physical therapy that targets rehabilitation of walking and standing functions
干预措施: Physical Therapy (Other)
结局指标
主要结局
Six-Minute Walk Test
时间窗: 1-11 months
Measurement of walking ability. The distance is reported in meter.
Two-minute walk test
时间窗: 1-11 months
A measurement of endurance that assesses walking distance over two minutes.
次要结局
- Kinetic and kinematic gait analysis using 3D camera system(1-11 months)
- Electromyography recording of lower extremity and trunk muscles(1-11 months)
- Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire(1-11 months)
- Spinal Cord Injury - Functional Index (SCI-FI) questionnaire(1-11 months)
- Modified Ashworth Scale(1-11 months)
- Neurogenic Bowel Dysfunction Score(1-11 months)
- Neurogenic Bladder Symptom Score(1-11 months)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination(1-11 months)
- Somatosensory evoked potentials(1-11 months)
- Motor evoked potentials(1-11 months)
- Berg Balance Test(1-11 months)
- Ten-meter walk test(1-11 months)
- Gait analysis(1-11 months)
- Spinal Cord Injury - Functional Index (SCI-FI) questionnaire(1-11 months)
- Modified Ashworth Scale(1-11 months)
- Neurogenic Bowel Dysfunction Score(1-11 months)
- Neurogenic Bladder Symptom Score(1-11 months)
- Motor evoked potentials(1-11 months)
- Kinetic and kinematic gait analysis using 3D camera system(1-11 months)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination(1-11 months)
- Somatosensory evoked potentials(1-11 months)
- Electromyography recording of lower extremity and trunk muscles(1-11 months)
- Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire(1-11 months)
研究者
Chet Moritz
Associate Professor
University of Washington