New stimulation combo aims to restore movement in spinal cord injury
NCT ID NCT06494059
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach that combines magnetic brain stimulation, electrical spinal cord stimulation, and muscle stimulation to improve hand, leg, and trunk function in people with spinal cord injury. Researchers will enroll 25 participants, including both injured and able-bodied individuals, to measure changes in dexterity, foot tapping, sitting balance, and brain-to-muscle connections. The goal is to see if this synchronized stimulation can help restore movement and function.
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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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2026
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 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: Male or Female subjects 1. At least 18 years old and no older than 70 years old at the time of enrollment. 2. Able-bodied subjects 3. Traumatic spinal cord injury 4. Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory; * Lower limb target: neurological level at or above Thoracic 10 level, with residual lower limb function; AIS B, C or D impairment grade primary could ambulate; * Trunk target: neurological at or above Thoracic 5, AIS A, B, C or D impairment grade, primary wheelchair user 5. Spinal cord injury sustained more than 6 months prior to study. 6. Movement/excitability/etc: * Upper limb target: Has detectable residual connection in upper-limb muscles in at least one side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) and a visible contraction when functional electrical stimulation (FES) is applied in the hand or wrist muscle at baseline. * Lower limb target: Has detectable residual connection in lower-limb muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in lower limb ankle plantar or dorsiflexor muscle at baseline. * Trunk target: Has detectable residual connection in trunk muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in trunk muscle at baseline. 7. Able to commit to intervention and assessment sessions over a maximum duration of 2 months. Exclusion Criteria: 1. Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function. 2. Has severe spasticity that could prevent the study protocol as determined by the investigator. 3. Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities. 4. Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease. 5. Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS. 6. Has a history of prior intracranial surgery or known medical risks that would limit TMS protocols. 7. Has a history of epilepsy, convulsion or seizures. 8. Individuals with metal implants in their head or spine near the sites to be stimulated and other implantable devices (e.g., cochlear implants) in the body that could be affected by TMS or TSCS. 9. Has implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation or VNS). 10. Has a cardiac pacemaker or intracardiac lines. 11. Has peripheral neuropathy, including diabetic polyneuropathy and entrapment neuropathy. 12. Has urinary tract infection, unhealed fracture, contracture, and pressure sore as determined by Braden Scale value of 14 and below. 13. Individuals who require therapy or other care that could interfere with participation in the study. 14. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function. 15. Individuals with substance disorders, including alcoholism and drug abuse. 16. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study. 17. 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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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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Other studies related to the condition(s) this trial covers.
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