Spinal zaps and drug combo aim to boost mobility in kids with cerebral palsy
NCT ID NCT07433023
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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4 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shirley Ryan AbilityLab
RECRUITINGChicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Zapping the spine while wearing a robotic ankle: a new way to help kids walk?
- Can virtual reality rewire balance and leg control in cerebral palsy?
- AI learns to spot the two cues that define cerebral palsy motor levels
- Zapping the spine: a Non-Invasive device aims to loosen stiff muscles and improve walking in cerebral palsy
- Robots map how brain and nerve injuries disrupt everyday arm tasks
- Can modified music tunes boost balance in kids with cerebral palsy?