Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
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.
Description
This project will investigate the impact of transcutaneous spinal cord stimulation (tSCS) on gait and activity-based training in children with Cerebral Palsy. Through a 1:1 randomization, a subset of participants will also receive a dose of 5-azacitidine (AZA), an FDA-approved drug for pediatric oncology, or a placebo. Research in muscle fibers as shown that AZA aids in muscle growth and regeneration. The use of AZA in this study is an off-label application, employed together with the tSCS intervention to investigate the impact of targeting both muscular and mechanical deficits related to CP.…
Eligibility
- Age range
- 4–17 years
- Sex
- All
- Healthy volunteers
- No
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 acc…
Interventions
- OthertSCS
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.
- Drug5-Azacitidine
A subset of opt-in participants will receive a single subcutaneous injection of 5-Azacitidine at a dose of 75 mg/m²
- DrugMannitol
A subset of opt-in participants will receive a single subcutaneous injection of Mannitol (placebo) at a dose of 75 mg/m².
- OtherFunctional 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.
Location
- Shirley Ryan AbilityLabChicago, Illinois