Could a painless electrical patch on the back restore movement after spinal injury?
NCT ID NCT06520020
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This study tests whether a non-invasive electrical stimulation device placed on the skin over the spinal cord is safe and practical for people with spinal cord injury. It includes 30 adults with either non-traumatic spinal cord injury (from cervical myelopathy) or traumatic injury (recent or delayed). The goal is to see if the device can be used without harm and to measure any changes in movement, sensation, and daily 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 cord stimulation (electrical stimulation device)
- What this could lead to
- If successful, this approach could offer a non-invasive way to improve movement and sensation in people with spinal cord injury.
- What could go wrong
- This is a small, early pilot study focused on safety, not effectiveness. The results may not apply to all types of spinal cord injury, and individual responses may vary.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 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 to 80 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: * Age: = 18 years and = 80 years. * Written informed consent by patient and/or legal authorized representative (LAR). * No other life-threatening condition. * No evidence of sepsis. * No evidence of superficial skin infection at site of surgery and intervention. * An established diagnosis of either: * cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or * acute cervical / thoracic SCI with ASIA Impairment Scale grade A-D (as assessed within 72 hours of injury) with neurologic level of injury (NLI) from C2 to T12. * The ability to undergo, or have had, surgical intervention. -. The ability to undergo transcutaneous intervention including study procedures in the posterior cervical or thoracic midline at or after 14 days from surgery. Exclusion Criteria: * Any concomitant impairment of the upper and lower limb at baseline that could potentially confound the neurologic assessments; including but not limited to traumatic or disease conditions like brachial plexus injury, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, and Parkinson's disease. * mJOA of \>= 15 and \<= 7, or AIS grade E tSCI at baseline assessment. * Currently involved in another non-observational ntSCI or tSCI study, or receiving another interventional drug, that could interfere with recordings and confound adverse events. * Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon and/or principal investigator. * Unable to commit to the follow-up schedule. * Recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study. * Any condition likely to result in the patient's death within the next 12 months. * Prisoner. * Pregnancy. * Cardiac pacemaker dependent, unable to undergo electrical stimulation. * Brain implant, skull prosthesis, plate and screws limiting transcranial stimulation. * Tattoo at site of skin electrode that causes heat/pain during stimulation. * Subjects who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.
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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 Kentucky - Chandler Medical Center
RECRUITINGLexington, Kentucky, 40536-0298, United States
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