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Spinal Cord Stimulation for Children With Cerebral Palsy

NCT07516067 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-07

No results posted yet for this study

Summary

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

Conditions

  • Cerebral Palsy
  • Spasticity

Interventions

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.

Sponsors & Collaborators

  • Martin Piazza

    lead OTHER

Principal Investigators

  • Martin G Piazza, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516067 on ClinicalTrials.gov