Spinal stimulation may unlock better hand control after injury
NCT ID NCT06494020
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This study tests whether combining hand practice with a non-invasive spinal cord stimulation technique can reduce muscle tightness and improve hand function in people with chronic cervical spinal cord injury. Participants will perform hand tasks while receiving transcutaneous spinal cord stimulation three times a week. The goal is to see if higher stimulation frequencies can ease spasticity and enhance motor performance.
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 (TcSCS) combined with hand task practice
- What this could lead to
- If effective, this combination could offer a non-invasive way to improve hand function and reduce spasticity in people with chronic spinal cord injury.
- What could go wrong
- This is a very small early study (6 participants), so results may not apply broadly. The intervention may not reduce spasticity or improve function, and there are risks like discomfort or skin irritation from stimulation.
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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 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Oct 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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22 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: * 22-70 years of age * Non-progressive cervical spinal cord injury * Minimum 12 months year post-injury. * American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D. * Able to take part in upper extremity therapy procedures. * GRASSP-Prehension score ≥10. * MAS Score ≥3 but \<6 in at least one arm. * Can commit to the time required for the study. * Stable medication profile for at least 4 weeks prior to enrollment. * Able to reduce Baclofen dose to 30 mg or less daily. * Capable of providing informed consent. Exclusion Criteria: * Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders. * Has uncontrolled cardiopulmonary disease or cardiac symptoms. * Requires ventilator support. * Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled. * Has an autoimmune etiology of spinal cord dysfunction/injury * Previously diagnosed as having transverse myelitis * History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures. * Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) * Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change. * Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment. * Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment. * Breakdown in skin area that will come into contact with electrodes. * Presence of syringomyelia as determined by an MRI. * Currently undergoing treatment for cancer or has been in remission for less than 2 years. * Received stem cell treatment within the past two years prior to enrollment. * Has any active implanted medical device. * Concurrent participation in another drug or device trial that may interfere with this study. * In the opinion of the investigators, the study is not safe or appropriate for the participant. * Persons who are unable to consent, pregnant women, and prisoners.
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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.
Contacts and locations
Locations
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University of Miami - Christine E. Lynn Rehabilitation Center
Miami, Florida, 33136, United States
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University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis
Miami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can magnetic pulses to the brain restore hand control after spinal injury?
- Spinal zaps may calm muscle spasms after injury
- Mind over matter: can a wireless brain implant restore control for the paralyzed?
- Spinal cord zap may help people breathe again after neck injury
- Core exercises show promise for kids with cerebral palsy
- Hands-Free faucet gives independence back to spinal cord injury patients