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Can a drug plus nerve training restore leg movement after paralysis?

NCT ID NCT05447676

Disease control Sponsor: Shirley Ryan AbilityLab 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed early-phase trial tested whether the drug 4-AP (dalfampridine), combined with special nerve stimulation and leg exercises, could improve muscle strength and control in people with spinal cord injury. 26 adults with injuries at or above the lower back took part. The goal was to see if this combination could boost the brain's ability to send signals past the injury site.

What this could mean

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

Active substance
Dalfampridine (4-AP)
What this could lead to
If successful, this approach could point toward a way to improve leg movement and strength in people with spinal cord injury.
What could go wrong
This is a very early, small trial (26 people) testing a combination of therapies, so results may not be strong or widely applicable. The drug can have side effects like dizziness or urinary tract infections.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

26 people

The number who actually took part.

Started

Jun 2022

Finished

Jun 2025

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

18 to 85 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: * Male and females between ages 18-85 years * SCI at least 4 weeks post injury * Spinal Cord injury at or above L2 * ASIA A,B,C, or D, complete or incomplete * Possess the following abilities * The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles Exclusion Criteria: * Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease * Any history of renal impairment * Any debilitating disease prior to the SCI that caused exercise intolerance * Premorbid, ongoing major depression or psychosis, altered cognitive status * History of head injury or stroke * Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication * History of seizures or epilepsy * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold (see appendix 2) * Pregnant females * If a women of child bearing age is unsure of the pregnancy, and does not want to take the pregnancy test Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk * Metal plate in skull * Individuals with scalp shrapnel, cochlear implants, or aneurysm clips * Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs

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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.

Spinal cord injury

Contacts and locations

Locations

  • Shirley Ryan Abilitylab

    Chicago, Illinois, 60611, United States

More trials for these conditions

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