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Spinal zaps and drug combo aim to boost mobility in kids with cerebral palsy

NCT ID NCT07433023

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 16-week program of spinal stimulation (using electrodes on the skin) combined with walking or activity training can improve movement in children with cerebral palsy. Some participants can also choose to receive a single injection of a drug called 5-Azacitidine or a placebo to see if it adds extra benefit. The trial includes 80 children aged 4 to 17 with different levels of mobility.

What this could mean

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

Active substance
transcutaneous spinal stimulation and 5-Azacitidine (a drug)
What this could lead to
If it works, this could point toward a new way to improve walking and movement in children with cerebral palsy.
What could go wrong
This is a Phase 2 trial with only 80 participants, so results are early and may not apply to everyone. The drug part is optional and small, so its effect is uncertain.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Started

May 2026

Expected to finish

Jan 2029

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

4 to 17 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: * Diagnosis of cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) Levels I-V. * Between 4 and 17 years old at the time of enrollment/consent. * Diagnosis of spastic CP hemiplegia, diplegia, or quadriplegia. * Stable medical condition as determined by the investigator. * Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator. * Capable of performing simple cued motor tasks and can follow 2-3 step commands. * Capable of communicating an accurate yes or no answer to questions according to parent or guardian. * Able to localize pain/ discomfort. * Physician approval for participation. * Parent/ guardian permission. Exclusion Criteria: * Concurrent neurological disease affecting the central nervous system. * Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention * Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the upper and/or lower extremity * Unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities * Implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant) or drug delivery device (e.g., baclofen pump) * Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker, implanted drug pump), ventilation support, or another external device. * History of uncontrolled seizures * Unexplained presence of persistent complaints of pain of any kind * Unable to localize pain/discomfort * Severe cortico-visual impairment * Active pressure sores * Active urinary tract infection * Active cancer or cancer in remission less than 5 years * Clinically significant depression, psychiatric disorders, or ongoing drug abuse * Immunodeficiency or hematologic condition * Allergy to AZA or mannitol * Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 10 * Pregnancy * Orthopedic surgery completed in the prior 12 months * Intrathecal medication titration that may affect muscle spasticity * Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the treating physician * Current enrollment in a conflicting research study * Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the investigator or treating physician

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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

  • Shirley Ryan AbilityLab

    RECRUITING

    Chicago, Illinois, 60611, United States

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