Transcutaneous Spinal Stimulation and Exercise for Locomotion

Официальное название

Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion

Обзор

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.

Вмешательства

• Устройство Transcutaneous spinal stimulation
  Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions
• Другое Physical Therapy
  physical therapy to improve walking and standing functions

Первичные конечные точки

• Six-Minute Walk Test [Срок оценки: 1-11 months]
• Two-minute walk test [Срок оценки: 1-11 months]

Вторичные конечные точки (12)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination [Срок оценки: 1-11 months]
• Somatosensory evoked potentials [Срок оценки: 1-11 months]
• Somatosensory evoked potentials [Срок оценки: 1-11 months]
• Motor evoked potentials [Срок оценки: 1-11 months]
• Motor evoked potentials [Срок оценки: 1-11 months]
• Berg Balance Test [Срок оценки: 1-11 months]
• Ten-meter walk test [Срок оценки: 1-11 months]
• Gait analysis [Срок оценки: 1-11 months]
• Kinetic and kinematic gait analysis using 3D camera system [Срок оценки: 1-11 months]
• Electromyography recording of lower extremity and trunk muscles [Срок оценки: 1-11 months]
• Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire [Срок оценки: 1-11 months]
• Spinal Cord Injury - Functional Index (SCI-FI) questionnaire [Срок оценки: 1-11 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Washington — Seattle

Идентификаторы

NCT: NCT03509558 · STUDY00003070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗