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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT07433023
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • tSCS — OTHER
    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 — DRUG
    A subset of opt-in participants will receive a single subcutaneous injection of 5-Azacitidine at a dose of 75 mg/m²
  • Mannitol — DRUG
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
May 28, 2026
Status verified
May 2026
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Spatiotemporal Gait Symmetry via Instrumented Gait-Mat [ Time Frame: Baseline to Follow-Up, approximately 22 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Arun Jayaraman, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Shirley Ryan AbilityLab· Chicago, IL

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