Spinal Cord Stimulation for Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorMartin Piazza
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Spinal Cord Stimulation (tSCS)
DeviceTranscutaneous 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Cerebral Palsy GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in H-reflex with Transcutaneous Spinal Cord Stimulation
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.
Time frame
Measured during 1 of up to 3 research sessions over up to 16 weeks2
Modified Ashworth Scale
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.
Time frame
Measured during 1 of up to 3 research sessions over up to 16 weeksSecondary outcomes
1
TMS motor evoked potential
A reduction in TMS motor evoked potential with tSCS is expected. Success criteria is measured as a decrease in 20 percent of the peak-to-peak amplitude with tSCS.
Time frame
Measured during 1 of up to 3 research sessions over up to 16 weeks2
Reciprocal inhibition between antagonist muscles with tSCS
Reciprocal inhibition will be tested by conditioning the H-reflex (elicited by stimulating at the tibial nerve) with a prior (between 1 and 5 ms) stimulation of the deep peroneal nerve. The results will be compared in CP vs control to determine its contribution in spinal hyperexcitability in CP. Additionally, the effect of tSCS in CP will be compared to determine whether tSCS can normalize hyperexcitability in CP. Success criteria is measured as a change in reciprocal inhibition of 20 percent towards the values in control participants.
Time frame
Measured during 1 of up to 3 research sessions over up to 16 weeks3
Motoneuron excitability
The investigators will measure the persistent inward currents of motoneurons as a measure of motoneuron excitability . A reduction in persistent inward current with tSCS is expected. The investigators will compare the results in CP vs control to determine its contribution in spinal hyperexcitability in CP. Additionally, the effect of tSCS in CP will be compared to determine whether tSCS can normalize hyperexcitability in CP. Success criteria is measured as a change in motoneuron excitability of 20 percent towards the values obtained in control participants.
Time frame
Measured during 1 of up to 3 research sessions over up to 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Martin Piazza
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov