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NOT YET RECRUITING
NCT07433023
PHASE2

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

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

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

OTHER

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.

DRUG

5-Azacitidine

A subset of opt-in participants will receive a single subcutaneous injection of 5-Azacitidine at a dose of 75 mg/m²

DRUG

Mannitol

A subset of opt-in participants will receive a single subcutaneous injection of Mannitol (placebo) at a dose of 75 mg/m².

OTHER

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