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Surgery may give paralyzed patients a helping hand

NCT ID NCT04023591

Disease control Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 study tests whether nerve transfer surgery can improve arm and hand function in people with complete spinal cord injuries who have no hand movement. Seventy participants will undergo surgery followed by 48 months of occupational therapy. The goal is to help them regain independence and quality of life.

What this could mean

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

Active substance
nerve transfer surgery
What this could lead to
If successful, this surgery could restore meaningful arm and hand function in people with paralysis, helping them perform daily tasks and live more independently.
What could go wrong
This is a small, early-stage study with only 70 participants, and results may not apply to everyone. Surgery carries risks like infection or nerve damage, and recovery requires years of therapy.

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.

Participants

About 70 people

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

Started

Apr 2020

Expected to finish

Dec 2030

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.

Who is studied

Participants with a traumatic cervical spine injury with little to no use of his/her arms/hands.

Ages

18 to 65 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 1. Age 18-65, inclusive 2. At least 3 months of non-operative rehab therapy 3. Mentally and physically willing and able to comply with evaluations 4. Less than 36 months post-injury 5. Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months 6. ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) 7. EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury 8. Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function 9. Injury Level C4-C8 Exclusion Criteria 1. Active infection at the operative site or systemic infection 2. Any return or ongoing clinical recovery of distal motor function 3. Mentally or physically compromised that will prevent them from complying with evaluations. 4. Immunologically suppressed 5. Currently undergoing long-term steroid therapy 6. Active malignancy 7. Pregnant 8. Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion 9. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits. 10. Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.

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Conditions

The condition(s) this trial relates to.

quadriplegia spinal cord injury

As listed by the trial registrant

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

Quadriplegia flaccid Spinal cord injuries Tetraplegia

Contacts and locations

Locations

  • Alberta Health Services - Foothills Medical Center

    Calgary, Alberta, T2N 2T9, Canada

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Stanford University

    Stanford, California, 94305, United States

  • University of Alberta

    Edmonton, Alberta, T6G 2E1, Canada

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.