Transcutaneous Spinal Stimulation and Exercise for Locomotion

Launched by UNIVERSITY OF WASHINGTON · Apr 25, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring how a combination of non-invasive electrical stimulation of the spinal cord and intensive physical therapy can help improve movement and function in people with spinal cord injuries, particularly those with incomplete tetraplegia or paraplegia. The goal is to see if these treatments can enhance the ability to walk and improve the use of arms and hands. Participants will undergo different phases of therapy, including a month of physical therapy alone and then a month of combined therapy, with sessions lasting up to two hours, two to five days a week.

To be eligible for the trial, participants need to be between 21 and 70 years old, have a spinal cord injury for at least a year, and have difficulty with movement and daily activities. They should also be in stable health and able to attend therapy sessions regularly. Throughout the study, participants can expect to engage in various exercises and therapies aimed at improving their mobility, and they will be monitored for any improvements in their upper and lower body function. It’s important for potential participants to have support from family or friends to help them through this commitment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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 in the anteroposterior lumbar spine and/or proximal femur measured by DEXA (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