Can a smart stimulator restore hand function after spinal cord injury?
NCT ID NCT05267951
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial tests whether a non-invasive spinal cord stimulation device that turns on and off based on muscle signals can improve hand and arm function in people with spinal cord injury. Participants will receive both closed-loop stimulation (which responds to their own muscle activity) and open-loop stimulation (continuous), along with intensive exercise therapy. The study measures changes in strength, sensation, hand function, and spasticity to see if this approach could aid recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation
- What this could lead to
- If effective, this approach could offer a non-invasive way to improve hand and arm function and reduce spasticity in people with spinal cord injury.
- What could go wrong
- This is a small early-stage trial, so results may not apply broadly. The stimulation is experimental and may not work for everyone, and there is a risk of discomfort or no benefit.
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
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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
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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21 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. has cervical (C8 or higher), incomplete (American Spinal Cord Injury Impairment Scale - C or D) traumatic spinal cord injury, minimum 1-year post-injury 2. has difficulty with hand functions in activities of daily living (e.g., dressing, grooming, feeding) 3. stable medical condition without cardiopulmonary disease or autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities 4. capable of performing simple cued motor tasks 5. has ability to attend intervention/functional task training and assessment sessions 3 times/week 6. has adequate social support to participate in all intervention and baseline/follow-up assessment sessions throughout 40 weeks. 7. has ability to read and speak English Exclusion Criteria: 1. dependent on ventilation support 2. has implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump 3. has metallic devices and implants in the head (e.g., deep brain stimulators, aneurysm clips/coils, and stents, vagus nerve stimulators) 4. has a history or current signs/symptoms of syringomyelia (progressive pain, muscle weakness, and/or sensory loss; deterioration of bowel/bladder function) 5. has autoimmune etiology of spinal cord dysfunction/injury 6. has received botulinum toxin injections in upper extremity muscles in the prior 6 months 7. has tendon transfer or nerve transfer surgery in the upper extremity, 8. taking tizanidine, dantrolene or diazepam 9. has history of seizures or increased risk for seizures 10. has history of chronic headaches or migraines 11. has history of neurologic diseases, such as stroke, multiple sclerosis, traumatic brain injury, etc. 12. has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) 13. has rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.) 14. 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 15. has cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention 16. unhealed fracture, contracture, pressure sore, or frequent urinary tract infections or other illnesses that might interfere with upper extremity rehabilitation or testing activities 17. has a history of severe allergy (i.e., allergic reaction that could not be treated with antihistaminic medication 18. has alcohol and/or drug abuse (subject's verbal statement) 19. has cancer 20. pregnant (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation and/or Transcranial Magnetic Stimulation whether the participant could be pregnant. Pregnancy will be ruled out by an over-the-counter urine pregnancy test for all females of childbearing potential (1) at the time of enrollment, (2) prior to all sessions that include Transcranial Magnetic Stimulation, and also prior to the intervention phases of (3) closed-loop or (4) open-loop stimulation. Additional pregnancy tests may be performed if there is a concern of pregnancy.) 21. lack of ability to fully comprehend, cooperate and/or safely perform study procedures in the investigator's opinion/judgment 22. unable to read and/or comprehend the consent form
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Washington
RECRUITINGSeattle, Washington, 98195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?