Transcutaneous Spinal Stimulation and Exercise for Locomotion in Spinal Cord Injury

This study is exploring if combining transcutaneous spinal stimulation (a non-invasive electrical stimulation of the spinal cord through the skin) with physical therapy can improve walking and standing for people with spinal cord injuries. Researchers believe this electrical stimulation might help by changing how the spinal cord's circuits work. You might be able to join if you are 21 to 70 years old, have had a spinal cord injury (T12 or higher) for at least a year, and have difficulty with leg movement and daily activities like walking or standing. The study will measure success by looking at how far participants can walk in six minutes and two minutes, with measurements taken between 1 and 11 months. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is an interventional study planning to enroll 20 participants. It is testing transcutaneous spinal stimulation combined with physical therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 to 11 months to measure walking ability.

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NCT03509558

Transcutaneous Spinal Stimulation and Exercise for Locomotion

Recruiting
NAAges 21–70InterventionalTreatment
University of Washington
~20 participants
Updated 2025-08-05 on ClinicalTrials.gov
What's tested:Transcutaneous spinal stimulationPhysical Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Six-Minute Walk Test
Measured over 1-11 months
+1 more outcome measured
Spinal Cord Injuries
1 sites across 1 states
Washington1

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Eligibility criteria

Inclusion

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

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
  • Six-Minute Walk Test1-11 months

    Measurement of walking ability. The distance is reported in meter.

  • Two-minute walk test1-11 months

    A measurement of endurance that assesses walking distance over two minutes.