NCT07433023 tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 80 participants in total. It began in 2026-05-28 with a primary completion date of 2030-08-31.

Brief Summary

This is an intervention study to investigate the impact of spinal stimulation on mobility outcomes in children with Cerebral Palsy. Participants will complete a 16-week training program with weekly sessions of spinal stimulation and walking or activity-based training. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the spinal stimulation to further affect mobility outcomes.

Eligibility Criteria

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

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