Improving movement in people with spinal cord injuries using electrical stimulation and exercise
Official title: Transcutaneous Spinal Stimulation With Intensive Physical Therapy for Locomotion
Run by University of Washington · NCT03509558 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 70 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | February 28, 2018 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT03509558 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 to 70 with a spinal cord injury at the T12 level or higher, experiencing mobility difficulties.
✕Probably not a fit
Patients with autoimmune conditions or those unable to participate in physical therapy sessions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with similar electrical stimulation techniques, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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University of Washington
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Soshi Samejima, DPT, MS
- Email: soshis@uw.edu
- Phone: 206 221-8961
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury
This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.
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NG004 for incomplete cervical spinal cord injury
This trial tests NG004 versus placebo to see if it is safe and helps motor function and daily life in adults with acute incomplete cervical spinal cord injury.
-
Robot-assisted training for arm and leg movement after stroke or injury
This study tests whether adding ZEPU-AI robotic training to usual therapy is safe and helps adults with arm or leg movement problems from stroke, spinal cord injury, brain injury, or orthopedic conditions.
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ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab
This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.
-
Combined magnetic stimulation and ultrasound for detrusor overactivity in spinal cord injury
This study tests whether using high-frequency sacral nerve stimulation together with bladder-directed ultrasound can reduce involuntary bladder contractions and improve bladder function in people with spinal cord injury.
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Hybrid HIIT-FES cycling program for people with spinal cord injury
This study tests a hybrid exercise program that combines functional electrical stimulation cycling with voluntary arm work to improve health in adults with spinal cord injury.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.