Spinal stimulation at home could restore arm movement after injury
NCT ID NCT06743607
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether non-invasive spinal stimulation, used at home with exercise, can safely improve arm and hand function in people with recent cervical spinal cord injury. 46 participants will be randomly assigned to start the program immediately or after a 12-week delay. The goal is to see if this approach is feasible and tolerable, and whether it leads to better upper extremity 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
- What this could lead to
- If it works, this could provide a safe, home-based way to improve arm and hand function after spinal cord injury.
- What could go wrong
- This is an early feasibility study with only 46 participants. The stimulation may not produce meaningful functional gains, and results may not apply to all injury types.
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 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Aug 2027
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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18 years and older
- 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: * Age 18 or older * History of traumatic SCI * Less than 12 months post SCI * SCI injury level C1-C8 * SCI categorized as AIS B-D * Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows * Have caregiver support to attend three in-person sessions and ongoing training at home * Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS * Able to complete in-person training sessions and return to Craig Hospital for assessments * Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation * If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures * Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device * Able to provide informed consent Exclusion Criteria: * Experience unstable chronic cardiac or respiratory complaints * Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention * Received Botox injections to the UEs, neck, or hands within the last three months * Pregnant, planning to become pregnant, or currently breastfeeding * Have breakdown in skin area that will come into contact with electrodes * Prior nerve or tendon transfer procedure for the UEs * Concurrently are participating in another drug or device trial that may interfere with this study * Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump * In the opinion of the investigators, the study is not safe or appropriate for the participant
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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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Craig Hospital
RECRUITINGEnglewood, Colorado, 80113, United States
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