Gentle spinal stimulation to reduce muscle tightness in children with cerebral palsy
Transcutaneous Spinal Cord Stimulation to Treat Spasticity in Children With Cerebral Palsy
This will try non-invasive, light spinal cord stimulation with movement tests to see if it reduces spasticity in children ages 5–17 with cerebral palsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07516067 on ClinicalTrials.gov |
What this trial studies
This interventional protocol compares spinal cord excitability in children with cerebral palsy and typically developing controls using surface electrophysiological recordings during isometric tasks. Investigators will collect markers such as sensory reflex responses, reciprocal inhibition, motoneuron firing patterns, and motor evoked potentials elicited by transcranial magnetic stimulation. In the patient group, the same measurements will be repeated while applying transcutaneous spinal cord stimulation (tSCS) to observe acute effects on spinal excitability and hypertonia. Procedures are non-invasive and involve movement/strength tasks plus mild stimulation that feels like a light tap.
Who should consider this trial
Good fit: Children aged 5–17 with a confirmed diagnosis of cerebral palsy, GMFCS levels I–IV, who can walk with or without assistance and can follow simple instructions are ideal candidates.
Not a fit: Children who are non-ambulatory (GMFCS V), have recent surgeries or unstable medical conditions, or cannot tolerate or follow the procedures are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, tSCS could provide a gentle, non-invasive way to reduce spasticity and improve motor control for some children with cerebral palsy.
How similar studies have performed: Small adult studies and early pediatric reports indicate tSCS can modulate spinal excitability, but robust pediatric evidence is limited and this application remains early-stage.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Martin G Piazza, MD — University of Pittsburgh
- Study coordinator: Bailey McDonald, BS
- Email: mcdonaldbm3@upmc.edu
- Phone: 412-692-9966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.