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Skin-Deep spinal stimulation: can zapping the spine help people walk again?

NCT ID NCT03509558

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers at the University of Washington are testing whether non-invasive electrical stimulation of the spinal cord through the skin, combined with intensive physical therapy, can improve walking and standing in people with spinal cord injuries. The trial enrolls 20 adults with incomplete tetraplegia or paraplegia who have had their injury for at least a year. Participants receive physical therapy with and without spinal stimulation, and researchers measure changes in walking speed, endurance, and neurological function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous spinal stimulation, a non-invasive electrical stimulation of the spinal cord through the skin, combined with physical therapy
What this could lead to
If it works, this could offer a non-surgical way to help people with spinal cord injuries improve walking and standing.
What could go wrong
This is a small early trial with 20 participants, so results may not apply broadly. The stimulation and therapy may not produce meaningful or lasting improvements for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

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Other studies related to the condition(s) this trial covers.