Cerebral Palsy Clinical Trials

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Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Shirley Ryan AbilityLab
RECRUITING
Chicago
Contact Information
Primary
Audrey Wiesner, BS
awiesner@sralab.org
3122388435
Backup
Jacklyn Stoller, PT, DPT
jstoller@sralab.org
3122387620
Time Frame
Start Date: 2026-05-28
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 80
Treatments
Active_comparator: tSCS + Functional Activity Training
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.
Experimental: tSCS + Functional Activity Training + 5-Azacitidine
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.
Active_comparator: tSCS + Functional Activity Training + Mannitol (Placebo)
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.
Related Therapeutic Areas
Sponsors
Leads: Shirley Ryan AbilityLab

This content was sourced from clinicaltrials.gov