Spinal Cord Stimulation for Children With Cerebral Palsy

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Martin Piazza
Study ID
NCT07516067
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Palsy
  • Spasticity

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Transcutaneous Spinal Cord Stimulation (tSCS) — DEVICE
    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.

Study Details

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

Key Dates

Start date
Mar 30, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in H-reflex with Transcutaneous Spinal Cord Stimulation [ Time Frame: Measured during 1 of up to 3 research sessions over up to 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Bailey McDonald, BS
[email protected]
412-692-9966
Martin G Piazza, MD
[email protected]
Martin G Piazza, MD (PRINCIPAL_INVESTIGATOR)
Genis Prat-Ortega, PhD (SUB_INVESTIGATOR)
Amit Sinha, MD (SUB_INVESTIGATOR)
George Wittenberg, MD, PhD (SUB_INVESTIGATOR)
Taylor Abel, MD (SUB_INVESTIGATOR)

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By research site
UPMC Children's Hospital of Pittsburgh· Pittsburgh, PA

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