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tSCS and 5-Azacitidine for Motor Outcomes in Cerebral Palsy

This study is looking at how spinal stimulation and a drug called 5-Azacitidine might help improve movement in children with Cerebral Palsy (CP). All participants will receive transcutaneous spinal cord stimulation (tSCS), which involves mild electrical stimulation to the spine, along with activity-based training for 16 weeks. Some participants will also have the option to receive a single injection of either 5-Azacitidine or a placebo (inactive substance) to see if it further helps with mobility. The study aims to see if these treatments can improve walking symmetry and reduce muscle stiffness. Children aged 4 to 17 with a diagnosis of spastic CP are eligible to join. The study is currently recruiting about 80 participants.

Study design
This is an interventional study involving about 80 participants. A subset of participants will be randomly assigned to receive either 5-Azacitidine or a placebo in addition to spinal stimulation.
What's involved
Participants will attend three 45-minute sessions per week for 16 weeks, involving spinal stimulation and activity-based training. Some participants will also receive a single subcutaneous injection.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 22 weeks after the start of the study to measure changes in gait and muscle tone.

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NCT07433023

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

Recruiting
PHASE2Ages 4–17Interventional
Shirley Ryan AbilityLab
~80 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:tSCS5-AzacitidineMannitolFunctional Activity Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Spatiotemporal Gait Symmetry via Instrumented Gait-Mat
Measured over Baseline to Follow-Up, approximately 22 weeks
+1 more outcome measured

Conditions

Cerebral Palsy

Explore related trials

Cerebral Palsy

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Arun Jayaraman, PhD · PRINCIPAL_INVESTIGATOR · Shirley Ryan AbilityLab

Who to contact

Audrey Wiesner, BS
[email protected]
3122388435
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Concurrent neurological disease affecting the central nervous system.
Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the upper and/or lower extremity
Unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities
Implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant) or drug delivery device (e.g., baclofen pump)
Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker, implanted drug pump), ventilation support, or another external device.
History of uncontrolled seizures
Unexplained presence of persistent complaints of pain of any kind
Unable to localize pain/discomfort
Severe cortico-visual impairment
Active pressure sores
Active urinary tract infection
Active cancer or cancer in remission less than 5 years
Clinically significant depression, psychiatric disorders, or ongoing drug abuse
Immunodeficiency or hematologic condition
Allergy to AZA or mannitol
Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 10
Pregnancy
Orthopedic surgery completed in the prior 12 months
Intrathecal medication titration that may affect muscle spasticity
Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the treating physician
Current enrollment in a conflicting research study
Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the investigator or treating physician

What this trial measures

  • Spatiotemporal Gait Symmetry via Instrumented Gait-MatBaseline to Follow-Up, approximately 22 weeks

    For Aim 1 participants (GMFCS levels 1-3), an instrumented gait-mat will be used to assess spatiotemporal gait symmetry.

  • Modified Tardieu ScaleBaseline to Follow-Up, approximately 22 weeks

    For Aim 2 participants (GMFCS levels 4-5), muscle spasticity will be assessed using the Modified Tardieu Scale.