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tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
Sponsor: Shirley Ryan AbilityLab
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.
Official title: Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
Key Details
Gender
All
Age Range
4 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-03-01
Completion Date
2029-01-01
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
tSCS
Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment.
5-Azacitidine
A subset of opt-in participants will receive a single subcutaneous injection of 5-Azacitidine at a dose of 75 mg/m²
Mannitol
A subset of opt-in participants will receive a single subcutaneous injection of Mannitol (placebo) at a dose of 75 mg/m².
Functional Activity Training
All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training. Participants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training.
Locations (1)
Shirley Ryan AbilityLab
Chicago, Illinois, United States