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Spinal Cord Stimulation for Children With Cerebral Palsy

This study is exploring how the spinal cord works in children with cerebral palsy (CP) and if a treatment called transcutaneous spinal cord stimulation (tSCS) can help reduce muscle stiffness (spasticity). tSCS uses a device that delivers mild electrical pulses to your back, feeling like a light tap. Researchers want to understand why children with CP have overactive spinal circuits and if tSCS can calm them down. You might be eligible if you are 5 to 17 years old with a confirmed CP diagnosis and can walk with or without help. Success in this study would mean seeing changes in your H-reflex (a measure of nerve activity) and improvements in your Modified Ashworth Scale score (which measures spasticity) after tSCS. The current status of this study is unclear, but it plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 30 participants, but the phase of the study is not specified.
What's involved
Participants will complete movement and strength exercises, receive mild, non-invasive stimulation on the back and legs, and undergo gentle tests to see how the brain and spinal cord communicate with muscles. These activities will occur during 1 of up to 3 research sessions over up to 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken during 1 of up to 3 research sessions over up to 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07516067

Spinal Cord Stimulation for Children With Cerebral Palsy

Recruiting
NAAges 5–17InterventionalTreatment
Martin Piazza
~30 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Transcutaneous Spinal Cord Stimulation (tSCS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in H-reflex with Transcutaneous Spinal Cord Stimulation
Measured over Measured during 1 of up to 3 research sessions over up to 16 weeks
+1 more outcome measured

Conditions

Cerebral Palsy
Spasticity

Explore related trials

Cerebral Palsy

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Martin G Piazza, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Bailey McDonald, BS
[email protected]
412-692-9966
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Children aged 5 to 17 years with a confirmed diagnosis of cerebral palsy.
Gross Motor Function Classification System (GMFCS) Levels I to IV, able to walk with or without assistance (walker or cane). This classification will have been completed by Dr. Martin Piazza and his Movement Disorders clinic team.
Stable medical condition without recent surgeries or interventions that could affect motor function.
Must be able to communicate basic needs and follow simple instructions.
Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.
Children aged 5 to 17 years with no history of neurological diagnoses.
Must be fully ambulatory without assistance.
Must be able to communicate basic needs and follow simple instructions.
Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.

Exclusion

Presence of implanted medical devices (e.g., baclofen pumps, deep brain stimulators) that may interfere with TSCS.
Severe scoliosis or spinal deformities that could affect the delivery of tSCS.
Uncontrolled epilepsy or a history of frequent seizures.
Severe cognitive impairments limiting the ability to comply with study procedures.
Skin conditions or open wounds at the site of stimulation.
Participation in other interventional studies that may confound results.
Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, etc.) that could affect ability to participate in this study.

What this trial measures

  • Change in H-reflex with Transcutaneous Spinal Cord StimulationMeasured during 1 of up to 3 research sessions over up to 16 weeks

    The primary outcome is H-reflex peak-to-peak amplitude with transcutaneous spinal cord stimulation (tSCS). Success criteria is measured as a reduction in 20 percent of peak-to-peak amplitude of the H-reflex.

  • Modified Ashworth ScaleMeasured during 1 of up to 3 research sessions over up to 16 weeks

    The primary outcome is the spasticity measured by the Modified Ashworth Scale with and without tSCS. The Modified Ashworth Scale is used to assess muscle spasticity. The scale is as follows: 0 = No increase in muscle tone; 1 = Slight increase in tone giving a catch when the limb is moved in flexion or extension; 1+ = Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM); 2 = More marked increase in tone through most of the ROM, but the limb easily flexed; 3 = Considerable increase in tone, passive movement difficult; 4 = Limb rigid in flexion or extension; Higher scores represent greater spasticity. Success criteria is measured as a reduction of at least 1 point in average across muscles. Scores will be averaged across assessed muscle groups to calculate a mean Modified Ashworth Scale score for each participant.