Recruiting
Phase 2

Spinal Stimulation, 5-Azacitidine

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT07433023

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

tSCS

5-Azacitidine

Mannitol

Functional Activity Training

Study Details

Brief 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.

Conditions

Cerebral Palsy

Study ID

NCT07433023

Start date

May 28, 2026

Status verified date

May, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

5-Azacitidine

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

Mannitol

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Audrey Wiesner, BS

3122388435awiesner@sralab.org

Jacklyn Stoller, PT, DPT

3122387620jstoller@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Arun Jayaraman, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Pediatric
  • Transcutaneous Spinal Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-05-29.