[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715006":3,"trial-entities:NCT07715006":99,"trial-summary:NCT07715006":102},{"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":23,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":60,"locations":62,"central_contacts":90,"overall_officials":94,"references":97,"see_also_links":98},"NCT07715006","STUDY26040193","Dorsal Root Electrical Stimulation in Children With Cerebral Palsy","Dorsal Root Electrical Stimulation to Suppress Spastic Muscle Activation in Children With Cerebral Palsy","RECRUITING","2029-12-01","2026-07","2026-07-20","2026-07-16","Martin Piazza","OTHER",false,"The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).","The investigators will recruit participants with CP requiring selective dorsal rhizotomy (SDR) surgery. During SDR, spastic dorsal roots are routinely identified by electrically stimulating each root at low frequency (1 Hz) and measuring the resulting muscle response via electromyography - a procedure called \"clinical test stimulation.\" Dorsal roots that produce an abnormally large and widespread compound muscle action potential (CMAP) are classified as spastic. In this study, the investigators will superimpose higher-frequency dorsal root stimulation (40-5000 Hz) on top of this standard clinical test stimulation and assess whether it suppresses the abnormal large CMAP.",[19,20,21,22],"Cerebral Palsy (CP)","Cerebral Palsy","Spasticity","Spasticity Due to Cerebral Palsy",[24],"Dorsal root electrical stimulation","INTERVENTIONAL","BASIC_SCIENCE",[28],"NA",{"count":30,"type":31},15,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Constant Current Stimulator","The DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters.",[38],"Cerebral Palsy Group",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Cadwell Guardian System","The Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR.",[38],[44],{"measure":45,"description":46,"timeFrame":47},"Peak-to-peak amplitude of the dorsal root reflex","The investigators will assess whether dorsal root electrical stimulation at frequencies (40-5000Hz) can normalize the abnormally large muscle response to electrical stimulation of the same dorsal root at low frequencies that is a signature of spasticity in CP. The investigators will measure the peak-to-peak amplitude of the dorsal root reflex with intramuscular EMGs.\n\nSucces criteria: A 20% reduction in the peak-to-peak amplitude of the spinal reflex","In session during the surgery (1 session)",[],"ALL","3 Years","14 Years",{"inclusion":53,"exclusion":58,"raw_text":59},[54,55,56,57],"Children ages 3 to 14","Diagnosis of Cerebral Palsy","Require an SDR as determined by the multidisciplinary movement disorders team","Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.",[],"Inclusion Criteria:\n\n* Children ages 3 to 14\n* Diagnosis of Cerebral Palsy\n* Require an SDR as determined by the multidisciplinary movement disorders team\n* Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.\n\nExclusion Criteria:\n\n* No exclusion criteria",[61],"CHILD",[63],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":87},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15224","United States",[70,75,78,80,83,85],{"name":71,"role":72,"phone":73,"email":74},"Bailey G McDonald, BS","CONTACT","412-692-9966","mcdonaldbm3@upmc.edu",{"name":76,"role":72,"email":77},"Martin G Piazza, MD","piazzamg@upmc.edu",{"name":76,"role":79},"PRINCIPAL_INVESTIGATOR",{"name":81,"role":82},"Genis Prat-Ortega, PhD","SUB_INVESTIGATOR",{"name":84,"role":82},"Taylor Abel, MD",{"name":86,"role":82},"Jeffrey Balzer, PhD",{"lat":88,"lon":89},40.44062,-79.99589,[91,93],{"name":92,"role":72,"phone":73,"email":74},"Bailey McDonald, BS",{"name":76,"role":72,"email":77},[95],{"name":76,"affiliation":96,"role":79},"University of Pittsburgh",[],[],{"nct_id":4,"conditions":100,"biomarkers":101},[20],[],{"nct_id":4,"found":103,"summary":104,"prompt_version":114},true,{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This interventional study plans to enroll 15 participants. It is not specified if it is randomized, blinded, or what phase it is in.","completed","Dorsal Root Electrical Stimulation for Spasticity in Children with Cerebral Palsy","This study is looking at whether a special type of electrical stimulation, called dorsal root electrical stimulation, can help reduce spasticity (muscle stiffness) in children with cerebral palsy (CP). Researchers will use two devices, the DS8R and the Cadwell Guardian System, to deliver controlled electrical pulses to the dorsal roots during a surgery called selective dorsal rhizotomy (SDR). This surgery is already a standard treatment for some children with CP. The study will measure how much the electrical stimulation changes the muscle response during the surgery. Children aged 3 to 14 with a diagnosis of CP who are already scheduled for SDR surgery are eligible to participate. The study is currently unclear on its recruitment status and plans to enroll 15 participants.","The primary endpoint is measured during the surgery session, so long-term follow-up is not specified beyond this.",122,"Participants will undergo dorsal root electrical stimulation during their scheduled selective dorsal rhizotomy (SDR) surgery. The primary measurement will occur during this single surgical session.","Not stated in the trial record.",[40],"v2"]