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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT07433023

Run by

Shirley Ryan AbilityLab

People needed

80

Starts

2026-05-28

Expected to finish

2029-01-01

Last updated by the study team

2026-05-29

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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