NCT07516067 · Martin Piazza
Spinal Cord Stimulation for Children With Cerebral Palsy
What this study is about
The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children.
View original scientific description
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.
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.
Primary outcome measures
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
The primary outcome is H-reflex peak-to-peak amplitude with transcutaneous spinal cord stimulation (tSCS). Success criteria is measured as a reduction in 20 percent of peak-to-peak amplitude of the H-reflex.
Modified Ashworth Scale
Time frame: Measured during 1 of up to 3 research sessions over up to 16 weeks
The primary outcome is the spasticity measured by the Modified Ashworth Scale with and without tSCS. The Modified Ashworth Scale is used to assess muscle spasticity. The scale is as follows: 0 = No increase in muscle tone; 1 = Slight increase in tone giving a catch when the limb is moved in flexion or extension; 1+ = Slight increase in muscle tone, indicated by a catch followed by minimal resistance throughout range of motion (ROM); 2 = More marked increase in tone through most of the ROM, but the limb easily flexed; 3 = Considerable increase in tone, passive movement difficult; 4 = Limb rigid in flexion or extension; Higher scores represent greater spasticity. Success criteria is measured as a reduction of at least 1 point in average across muscles. Scores will be averaged across assessed muscle groups to calculate a mean Modified Ashworth Scale score for each participant.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations