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tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
Who can join
Ages 4 to 17 · All sexes
Full 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 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
About the study
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.
What is being tested
- tSCS (other)
- 5-Azacitidine (drug)
- Mannitol (drug)
- Functional Activity Training (other)
Sponsor: Shirley Ryan AbilityLab · Participants: 80 · Started: May 28, 2026
Contact the study team
- Audrey Wiesner, BS · Phone: 3122388435
- Jacklyn Stoller, PT, DPT · Phone: 3122387620
Official record on ClinicalTrials.gov — NCT07433023
Locations in the U.S.
| Illinois | Shirley Ryan AbilityLab, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.