Improving movement in people with spinal cord injuries using electrical stimulation and exercise

Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion

This study is testing whether a mix of electrical stimulation and physical therapy can help people with spinal cord injuries move better and improve their daily lives.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years to 70 Years
• Sex: All
• Sponsor: University of Washington (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT03509558 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combined transcutaneous cervical and lumbosacral electrical stimulation along with intensive physical therapy on improving locomotion in individuals with spinal cord injuries. Participants will receive non-invasive electrical stimulation aimed at enhancing motor function in both lower and upper limbs. The approach is designed to be well-tolerated and painless, with the goal of improving daily mobility and overall quality of life. The study will assess the efficacy of this combined treatment over a period of up to 11 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 70 with a spinal cord injury at the T12 level or higher, experiencing mobility difficulties.

Not a fit: Patients with autoimmune conditions or those unable to participate in physical therapy sessions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance mobility and independence for patients with spinal cord injuries.

How similar studies have performed: Previous studies have shown promising results with similar electrical stimulation techniques, indicating potential for success in this approach.

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 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

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Soshi Samejima, DPT, MS

Conditions: Spinal Cord Injuries, Spinal electrical stimulation