Spinal stimulation may unlock better hand control after injury

NCT ID NCT06494020

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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 6 people

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

Started

Sep 2024

Expected to finish

Oct 2027

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

22 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: * 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.

Muscle Spasticity spinal cord injury

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Miami - Christine E. Lynn Rehabilitation Center

    Miami, Florida, 33136, United States

  • University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis

    Miami, Florida, 33136, United States

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