Spinal Cord Stimulation for Children With Cerebral Palsy

Transcutaneous Spinal Cord Stimulation to Treat Spasticity in Children With Cerebral Palsy

The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children. The main questions it aims to answer are:

• What are the mechanisms of spinal circuit hyperexcitability in CP?
• Can transcutaneous spinal cord stimulation reduce spinal circuit hyperexcitability?

Participants with cerebral palsy will be asked to complete:

• Movement and strength exercises
• Mild, non-invasive stimulation on the back and legs that feels like a light tap.
• Gentle, non-invasive tests that help us see how the brain and the spinal cord communicate with the muscles

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Spasticity
• Intervention / Treatment: Device: Transcutaneous Spinal Cord Stimulation (tSCS)

Detailed Description

This is a clinical trial designed to evaluate spinal circuit hyperexcitability in children with cerebral palsy (CP) and to explore the potential of transcutaneous spinal cord stimulation (tSCS) to reduce excitability and improve spasticity. The investigators will also examine the mechanisms underlying this potential reduction of spinal hyperexcitability.

The investigators will non-invasively record a range of electrophysiological responses using surface electrodes while participants perform isometric tasks. These recordings will help to better understand the differences in spinal excitability between children with CP and typically developing peers and will provide early insight into how tSCS might modulate these responses.

This study has two aims: The first aim is to evaluate spinal circuit excitability in Children with CP and in children without neurological conditions (controls). Several electrophysiological markers will be collected, including sensory reflex responses, reciprocal inhibition, motoneuron firing patterns, and motor evoked potential by transcranial magnetic stimulation. The second aim is to assess the impact of tSCS on spasticity and hypertonia in CP. To achieve this aim, the same electrophysiological measurements of spinal excitability will be repeated during non-invasive transcutaneous spinal cord stimulation in patient-participants (children with CP).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bailey McDonald, BS; Phone Number: 412-692-9966; Email: mcdonaldbm3@upmc.edu
• Study Contact Backup: Name: Martin G Piazza, MD; Email: piazzamg@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC Children's Hospital of Pittsburgh
      • Contact: Bailey McDonald, BS; Phone Number: 412-692-9966; Email: mcdonaldbm3@upmc.edu
      • Contact: Martin G Piazza, MD; Email: piazzamg@upmc.edu
      • Principal Investigator: Martin G Piazza, MD
      • Sub-Investigator: Genis Prat-Ortega, PhD
      • Sub-Investigator: Amit Sinha, MD
      • Sub-Investigator: George Wittenberg, MD, PhD
      • Sub-Investigator: Taylor Abel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

A. Patient-Participant Group (Children with Cerebral Palsy)

• 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.

B. Control Group (Children without Neurological Diagnoses)

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Cerebral Palsy Group; Transcutaneous spinal cord stimulation (tSCS) will be administered using the Digitimer DS8R Biphasic Constant Current Stimulator, an external isolated stimulator system used in human research. The DS8R delivers controlled electrical pulses with adjustable stimulation parameters. tSCS will be delivered at frequencies between 30-50 Hz with 1 ms pulse width and a biphasic waveform. Self-adhesive surface electrodes will be positioned longitudinally over the thoracolumbar region at T11-L1 (cathodes) and over the iliac crests (anodes). In children with cerebral palsy, electrophysiological and clinical assessments will be conducted before, during, and after stimulation to evaluate changes in spinal excitability, spasticity, and motor function. Stimulation is administered during supervised study visits.	Device: Transcutaneous Spinal Cord Stimulation (tSCS); Transcutaneous spinal cord stimulation (tSCS) will be administered using the Digitimer DS8R Biphasic Constant Current Stimulator, an external isolated stimulator system used in human research. The DS8R delivers controlled electrical pulses with adjustable stimulation parameters. tSCS will be delivered at frequencies between 30-50 Hz with 1 ms pulse width and a biphasic waveform. Self-adhesive surface electrodes will be positioned longitudinally over the thoracolumbar region at T11-L1 (cathodes) and over the iliac crests (anodes). In children with cerebral palsy, electrophysiological and clinical assessments will be conducted before, during, and after stimulation to evaluate changes in spinal excitability, spasticity, and motor function. Stimulation is administered during supervised study visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in H-reflex with Transcutaneous Spinal Cord Stimulation	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.	Measured during 1 of up to 3 research sessions over up to 16 weeks
Modified Ashworth Scale	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.	Measured during 1 of up to 3 research sessions over up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TMS motor evoked potential	A reduction in TMS motor evoked potential with tSCS is expected. Success criteria is measured as a decrease in 20 percent of the peak-to-peak amplitude with tSCS.	Measured during 1 of up to 3 research sessions over up to 16 weeks
Reciprocal inhibition between antagonist muscles with tSCS	Reciprocal inhibition will be tested by conditioning the H-reflex (elicited by stimulating at the tibial nerve) with a prior (between 1 and 5 ms) stimulation of the deep peroneal nerve. The results will be compared in CP vs control to determine its contribution in spinal hyperexcitability in CP. Additionally, the effect of tSCS in CP will be compared to determine whether tSCS can normalize hyperexcitability in CP. Success criteria is measured as a change in reciprocal inhibition of 20 percent towards the values in control participants.	Measured during 1 of up to 3 research sessions over up to 16 weeks
Motoneuron excitability	The investigators will measure the persistent inward currents of motoneurons as a measure of motoneuron excitability . A reduction in persistent inward current with tSCS is expected. The investigators will compare the results in CP vs control to determine its contribution in spinal hyperexcitability in CP. Additionally, the effect of tSCS in CP will be compared to determine whether tSCS can normalize hyperexcitability in CP. Success criteria is measured as a change in motoneuron excitability of 20 percent towards the values obtained in control participants.	Measured during 1 of up to 3 research sessions over up to 16 weeks

Collaborators and Investigators

• Sponsor: Martin Piazza
• Investigators: Principal Investigator: Martin G Piazza, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Spinal Cord Stimulation; Spasticity; TMS; transcranial magnetic stimulation; Transcutaneous Spinal Cord Stimulation; tSCS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy
• Other Study ID Numbers: STUDY25010142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No