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Spinal cord injury patients may regain hand function with implanted device

NCT ID NCT05863754

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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 13 people

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

Started

Jan 2022

Expected to finish

Dec 2028

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

16 years and older

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: * 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • MetroHealth Medical Center

    RECRUITING

    Cleveland, Ohio, 44109, United States

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