Spinal Stimulation + 5-Azacitidine for Cerebral Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Arun Jayaraman, PhD
Principal Investigator
Shirley Ryan AbilityLab
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Baseline
Participants undergo baseline assessments and blood draw for genetic and pre-intervention epigenetic profiling
Intervention
Participants receive transcutaneous spinal cord stimulation and activity-based training. A subset receives a single dose of 5-Azacitidine or placebo at midpoint.
Post-Intervention
Participants are monitored for long-term outcomes and undergo a second blood draw for post-intervention epigenetic profiling
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 5-Azacitidine
- tSCS
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Transcutaneous spinal cord stimulation will be paired with training based on Aim. Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS. Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate. A subset of opt-in participants will also be randomized to receive either 5-Azacitidine (VIDAZA) or placebo (Mannitol) at midpoint. A registered nurse will deliver a single subcutaneous injection of either AZA or placebo at a dose of 75 mg/m² to the participants lower abdomen or medial thigh.
Transcutaneous spinal cord stimulation will be paired with training based on Aim. Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS. Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate.
Transcutaneous spinal cord stimulation will be paired with training based on Aim. Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS. Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate. A subset of opt-in participants will also be randomized to receive either 5-Azacitidine (VIDAZA) or placebo (Mannitol) at midpoint. A registered nurse will deliver a single subcutaneous injection of either AZA or placebo at a dose of 75 mg/m² to the participants lower abdomen or medial thigh.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shirley Ryan AbilityLab
Lead Sponsor
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