Cerebral Palsy Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: t
View:

⁃ 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.

Locations
United States
Pennsylvania
UPMC Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Bailey McDonald, BS
mcdonaldbm3@upmc.edu
412-692-9966
Backup
Martin G Piazza, MD
piazzamg@upmc.edu
Time Frame
Start Date: 2026-03-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Martin Piazza

This content was sourced from clinicaltrials.gov