Transcutaneous spinal stimulation plus training with optional 5-Azacitidine for kids with cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will enroll children with cerebral palsy across GMFCS levels I–V to undergo a 16-week program of transcutaneous spinal cord stimulation (tSCS) combined with activity-based training, following a 2-week baseline period. A subset of participants will be randomized to receive 5-Azacitidine or placebo in addition to the tSCS and training, to explore potential additive effects on motor outcomes. The study will collect blood samples for genetic and epigenetic profiling to examine factors associated with response to the interventions. Primary goals are to improve gait symmetry, reduce muscle tone, and enhance functional mobility, with outcomes measured through standardized motor assessments. Safety monitoring and caregiver support will be integral throughout the three-phase protocol.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Arun Jayaraman, PhD — Shirley Ryan AbilityLab
• Study coordinator: Audrey Wiesner, BS
• Email: awiesner@sralab.org
• Phone: 3122388435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.