RecruitingNot ApplicableNCT07516067

Spinal Cord Stimulation for Children With Cerebral Palsy

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

Sponsor

Martin Piazza

Enrollment

30 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy Spasticity

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

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria11

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 Criteria7

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.

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Interventions

DEVICETranscutaneous 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.