[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07516067":3,"trial-entities:NCT07516067":121,"trial-summary:NCT07516067":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":49,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":81,"locations":83,"central_contacts":113,"overall_officials":116,"references":119,"see_also_links":120},"NCT07516067","STUDY25010142","Spinal Cord Stimulation for Children With Cerebral Palsy","Transcutaneous Spinal Cord Stimulation to Treat Spasticity in Children With Cerebral Palsy","RECRUITING","2026-12","2026-04","2026-04-07","2026-03-30","Martin Piazza","OTHER",false,"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:\n\n* What are the mechanisms of spinal circuit hyperexcitability in CP?\n* Can transcutaneous spinal cord stimulation reduce spinal circuit hyperexcitability?\n\nParticipants with cerebral palsy will be asked to complete:\n\n* Movement and strength exercises\n* Mild, non-invasive stimulation on the back and legs that feels like a light tap.\n* Gentle, non-invasive tests that help us see how the brain and the spinal cord communicate with the muscles","This is a clinical trial designed to evaluate spinal circuit hyperexcitability in children with cerebral palsy (CP) and to explore the potential of transcutaneous spinal cord stimulation (tSCS) to reduce excitability and improve spasticity. The investigators will also examine the mechanisms underlying this potential reduction of spinal hyperexcitability.\n\nThe investigators will non-invasively record a range of electrophysiological responses using surface electrodes while participants perform isometric tasks. These recordings will help to better understand the differences in spinal excitability between children with CP and typically developing peers and will provide early insight into how tSCS might modulate these responses.\n\nThis study has two aims: The first aim is to evaluate spinal circuit excitability in Children with CP and in children without neurological conditions (controls). Several electrophysiological markers will be collected, including sensory reflex responses, reciprocal inhibition, motoneuron firing patterns, and motor evoked potential by transcranial magnetic stimulation. The second aim is to assess the impact of tSCS on spasticity and hypertonia in CP. To achieve this aim, the same electrophysiological measurements of spinal excitability will be repeated during non-invasive transcutaneous spinal cord stimulation in patient-participants (children with CP).",[19,20],"Cerebral Palsy","Spasticity",[19,20,22,23,24,25,26],"Spinal Cord Stimulation","tSCS","TMS","Transcutaneous Spinal Cord Stimulation","transcranial magnetic stimulation","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},30,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"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.\n\ntSCS 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).\n\nIn 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.",[40],"Cerebral Palsy Group",[42,46],{"measure":43,"description":44,"timeFrame":45},"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).\n\nSuccess 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",{"measure":47,"description":48,"timeFrame":45},"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:\n\n0 = No increase in muscle tone;\n\n1 = Slight increase in tone giving a catch when the limb is moved in flexion or extension;\n\n1+ = 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;\n\nHigher 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.",[50,53,56],{"measure":51,"description":52,"timeFrame":45},"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.",{"measure":54,"description":55,"timeFrame":45},"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.",{"measure":57,"description":58,"timeFrame":45},"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.","ALL","5 Years","17 Years",true,{"inclusion":64,"exclusion":72,"raw_text":80},[65,66,67,68,69,70,71,68,69],"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.","Children aged 5 to 17 years with no history of neurological diagnoses.","Must be fully ambulatory without assistance.",[73,74,75,76,77,78,79],"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.","Inclusion Criteria:\n\nA. Patient-Participant Group (Children with Cerebral Palsy)\n\n* Children aged 5 to 17 years with a confirmed diagnosis of cerebral palsy.\n* 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.\n* Stable medical condition without recent surgeries or interventions that could affect motor function.\n* Must be able to communicate basic needs and follow simple instructions.\n* Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.\n\nB. Control Group (Children without Neurological Diagnoses)\n\n* Children aged 5 to 17 years with no history of neurological diagnoses.\n* Must be fully ambulatory without assistance.\n* Must be able to communicate basic needs and follow simple instructions.\n* Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.\n\nExclusion Criteria:\n\n* Presence of implanted medical devices (e.g., baclofen pumps, deep brain stimulators) that may interfere with TSCS.\n* Severe scoliosis or spinal deformities that could affect the delivery of tSCS.\n* Uncontrolled epilepsy or a history of frequent seizures.\n* Severe cognitive impairments limiting the ability to comply with study procedures.\n* Skin conditions or open wounds at the site of stimulation.\n* Participation in other interventional studies that may confound results.\n* Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, etc.) that could affect ability to participate in this study.",[82],"CHILD",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":110},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15224","United States",[91,96,99,101,104,106,108],{"name":92,"role":93,"phone":94,"email":95},"Bailey McDonald, BS","CONTACT","412-692-9966","mcdonaldbm3@upmc.edu",{"name":97,"role":93,"email":98},"Martin G Piazza, MD","piazzamg@upmc.edu",{"name":97,"role":100},"PRINCIPAL_INVESTIGATOR",{"name":102,"role":103},"Genis Prat-Ortega, PhD","SUB_INVESTIGATOR",{"name":105,"role":103},"Amit Sinha, MD",{"name":107,"role":103},"George Wittenberg, MD, PhD",{"name":109,"role":103},"Taylor Abel, MD",{"lat":111,"lon":112},40.44062,-79.99589,[114,115],{"name":92,"role":93,"phone":94,"email":95},{"name":97,"role":93,"email":98},[117],{"name":97,"affiliation":118,"role":100},"University of Pittsburgh",[],[],{"nct_id":4,"conditions":122,"biomarkers":123},[19],[],{"nct_id":4,"found":62,"summary":125,"prompt_version":134},{"design":126,"status":127,"heading":6,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 30 participants, but the phase of the study is not specified.","completed","This study is exploring how the spinal cord works in children with cerebral palsy (CP) and if a treatment called transcutaneous spinal cord stimulation (tSCS) can help reduce muscle stiffness (spasticity). tSCS uses a device that delivers mild electrical pulses to your back, feeling like a light tap. Researchers want to understand why children with CP have overactive spinal circuits and if tSCS can calm them down. You might be eligible if you are 5 to 17 years old with a confirmed CP diagnosis and can walk with or without help. Success in this study would mean seeing changes in your H-reflex (a measure of nerve activity) and improvements in your Modified Ashworth Scale score (which measures spasticity) after tSCS. The current status of this study is unclear, but it plans to enroll 30 participants.","Measurements will be taken during 1 of up to 3 research sessions over up to 16 weeks.",135,"Participants will complete movement and strength exercises, receive mild, non-invasive stimulation on the back and legs, and undergo gentle tests to see how the brain and spinal cord communicate with muscles. These activities will occur during 1 of up to 3 research sessions over up to 16 weeks.","Not stated in the trial record.",[37],"v2"]