NCT07516067|RecruitingFDA Device
Spinal Cord Stimulation for Children With Cerebral Palsy
Transcutaneous Spinal Cord Stimulation to Treat Spasticity in Children With Cerebral Palsy
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Transcutaneous Spinal Cord Stimulation to Treat Spasticity in Children With Cerebral Palsy
Sponsor study identifier
interventional
30
1 country
1
Study Start
March 30, 2026
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 27, 2026
Actual (reported)March 30, 2026
Actual (reported)April 7, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Measured during 1 of up to 3 research sessions over up to 16 weeks
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.
Measured during 1 of up to 3 research sessions over up to 16 weeks
TMS motor evoked potential
Measured during 1 of up to 3 research sessions over up to 16 weeks
Reciprocal inhibition between antagonist muscles with tSCS
Measured during 1 of up to 3 research sessions over up to 16 weeks
Motoneuron excitability
Measured during 1 of up to 3 research sessions over up to 16 weeks
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Martin G Piazza, MD
University of Pittsburgh
First Submitted
March 27, 2026
First Posted
April 7, 2026
Study Start
March 30, 2026
Actual (reported)Primary Completion
November 2026
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 7, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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