Spinal cord injury patients may regain hand function with implanted device
NCT ID NCT05863754
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests a device implanted in the arm that stimulates paralyzed muscles to help people with cervical spinal cord injury pick up and release objects. The study involves 13 participants and focuses on safety and how well the device improves hand function. It is an early-stage study, so results are not yet proven.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- implanted neuroprosthesis device
- What this could lead to
- If it works, this could provide a way for people with spinal cord injury to regain hand and arm function without needing lifelong medication.
- What could go wrong
- This is a very small early trial with only 13 participants, so results may not apply to everyone. The device requires surgery and may not work for all injury levels.
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 13 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2028
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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16 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: * Male or female, age \> 16 years. * Cervical level spinal cord injury, as defined by: 1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor level of C1 through C7 and 2. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, or C; * Six months or more post-injury (neurostability); * Neurologically stable following any nerve transfers affecting the upper extremity (typically, one year post surgery); * Musculoskeletally and neurologically stable following any tendon transfers affecting the upper extremity (typically, 6-months). * Peripheral nerve innervation to upper extremity muscles, including a grade 3/5 or higher Stimulated Manual Muscle Test (SMMT) strength in at least two of the following muscles in one arm: 1. Adductor Pollicus, Abductor Pollicus Brevis (AbPB), Flexor Pollicus Longus (FPL), Extensor Pollicus Longus (EPL)/Extensor Pollicus Brevis (EPB), Extensor Digitorum Communis (EDC), Flexor Digitorum Superficialis (FDS), Flexor Digitorum Profundus (FDP), Pronator Quadratus (PQ), Extensor Carpi Ulnaris (ECU), Extensor Carpi Radialis Brevis (ECRB), Extensor Carpi Radialis Longus (ECRL), Flexor Carpi Ulnaris (FCU), Flexor Carpi Radialis (FCR), First Dorsal Interosseous(1DI), triceps, 2. At least two of the grade 3/5 or higher excitable muscles must also have grade 2/5 or lower voluntary strength; * Good proximal upper extremity strength as defined by biceps/brachialis/brachioradialis strength of 2/5 or higher on Manual Muscle Test on the side intended for implantation; * Medically stable; * Able to understand and provide informed consent. Exclusion Criteria: * Other neurological conditions (MS(multiple Sclerosis), diabetes with peripheral nerve involvement); Associated peripheral nerve / brachial plexus injury * Progressive SCI; * Co-existing cervical spine pathology (syrinx, unstable segment) * Active implantable medical device (AIMD) such as a pacemaker or defibrillator; * Active untreated infection such as pressure injury, urinary tract infection, pneumonia; * History of coagulopathy, HIV, cardiopulmonary disease, bradycardia, poorly controlled autonomic dysreflexia, or chronic obstructive pulmonary disease that would preclude safe participation in the trial as determined by the investigator; * Unhealed fractures that prevent functional use of arm; * Extensive upper extremity denervation (fewer than two excitable hand muscles); * Involvement in other ongoing clinical studies that exclude concurrent involvement in this study; * Disorder or condition that requires MRI monitoring; * Mechanical ventilator dependency; * Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant); * Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study; * Other significant medical findings that, in the opinion of the investigator, preclude safe participation in the trial.
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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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MetroHealth Medical Center
RECRUITINGCleveland, Ohio, 44109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller
- Zapping the spine: a new hope for kids with paralysis?
- Can painless spinal zaps teach injured kids to walk again?