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Sleeve that reads muscle signals may restore hand grasp in paralysis

NCT ID NCT06087445

Disease control Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a sleeve worn on the forearm that uses muscle signals to stimulate hand muscles, helping people with tetraplegia from spinal cord injury grasp and manipulate objects. Twelve adults with chronic cervical SCI completed a 12-week training program using the device. Researchers measured safety, feasibility, and early improvements in hand function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NeuroLife EMG-FES Sleeve System (a non-invasive device with surface electrodes that records muscle activity and stimulates muscles to help hand function)
What this could lead to
If it works, this could provide a non-implant way for people with tetraplegia to regain some hand control, improving daily tasks like gripping and pinching.
What could go wrong
This was a small pilot study with only 12 participants, so results may not apply to everyone. The device is still experimental, and long-term benefits or risks are not yet known.

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

12 people

The number who actually took part.

Started

Oct 2023

Finished

May 2026

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 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: 1. age 22 years or older 2. sustained a chronic (\>12 months) cervical SCI (AIS A, B, C, or D) and is currently medically stable 3. unable to grasp and manipulate objects to allow independent performance of activities of daily living (e.g., Tetraplegia) 4. retain voluntary ability to enact unilateral shoulder and elbow movements either independently or with a mobile arm support 5. Willing and able to attend study sessions in Columbus, Ohio for 12 weeks, 3x/week and all assessment sessions (4 weeks prior to and 4 weeks following 12-week intervention protocol) 6. able to provide informed consent. Exclusion Criteria: 1. medical contraindications to FES (e.g., pacemaker or other implanted devices, uncontrolled seizure disorder, cancer or open wounds on hands) 2. severe, uncontrolled autonomic dysreflexia 3. comorbid medical condition that, in the opinion of the PI, that may impact participant safety or study results 4. severe upper extremity spasticity or contractures that prevent FES-evoked wrist and finger movements 5. ventilator dependent 6. pregnant or plan to become pregnant (females only) 7. actively participating in upper extremity rehabilitation.

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

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

Cervical spinal cord injury

Contacts and locations

Locations

  • Battelle Memorial Institute

    Columbus, Ohio, 43201, United States

  • Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)

    Columbus, Ohio, 43210, United States

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