[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07394608":3,"trial-entities:NCT07394608":122,"trial-summary:NCT07394608":125},{"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":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":42,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":95,"locations":97,"central_contacts":115,"overall_officials":117,"references":120,"see_also_links":121},"NCT07394608","STUDY-25-01164","Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation","Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial","RECRUITING","2028-03-01","2026-02","2026-03-13","2026-04","Icahn School of Medicine at Mount Sinai","OTHER",false,"This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy.",null,[19],"Cerebral Palsy",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},10,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DEVICE","Non-invasive taVNS","Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE).",[33],"Non-invasive VNS",[35,36],"Non-invasive, transauricular, vagus nerve stimulation device","Vagustim",[38],{"measure":39,"description":40,"timeFrame":41},"Number of adverse event and serious adverse events","Safety is assessed by adverse event.","12 months",[43,46,49,52,56,59,62,66],{"measure":44,"description":44,"timeFrame":45},"Number of therapy sessions complete","end of therapy visits at Day 46",{"measure":47,"description":48,"timeFrame":45},"Active training time per session","Number of minutes of training per session",{"measure":50,"description":51,"timeFrame":45},"Number of movement repetitions completed per session","Number of movement repetitions completed per session.",{"measure":53,"description":54,"timeFrame":55},"Jebsen Taylor Hand Function Test (JTHFT)","The Jebsen Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand functions that uses simulated activities of daily living (ADLs) assessed by time to completion; typically up to several minutes depending on impairment","baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months",{"measure":57,"description":58,"timeFrame":55},"BOT-2","The BOT-2 is a standardized assessment of motor proficiency in children and adolescents. It evaluates fine motor skills, manual dexterity, coordination, and motor integration through structured performance tasks.\n\nFine Motor Precision (Upper Extremity) scored 0-41, higher score indicates better precision Fine Motor Integration (Upper Extremity) scored 0-45, higher score indicates better integration Manual Dexterity (Upper Extremity) scored 0- 45, higher score indicates better manual dexterity.\n\nUpper-Limb Coordination scored 0-30, higher score indicates better upper-limb coordination.",{"measure":60,"description":61,"timeFrame":55},"ABILHANDS","ABILHAND is a patient-reported outcome measure that evaluates a person's perceived manual ability to perform daily bimanual activities. It assesses how difficult activities are to perform using both hands.\n\nThe ABILHAND-Kids logit score ranges from -6 logits to +6 logits, higher score indicates better bimanual manual ability (tasks are perceived as easier).",{"measure":63,"description":64,"timeFrame":65},"Pediatric Evaluation of Disability (PEDI)","The PEDI assesses functional abilities and performance in children across three domains: self-care, mobility, and social function. It measures both capability and caregiver assistance.\n\nSubscale range and full range uses scaled scores standardized to a 0-100 metric. Higher scores indicate better functional abilities and greater independence.","at 12 months",{"measure":67,"description":68,"timeFrame":55},"Pediatric Quality of Life Inventory (PedsQL)","The PedsQL is a standardized patient-reported outcome measure assessing health-related quality of life in children across domains including physical, emotional, social, and school functioning.\n\nSubscales range and full scale scores are transformed to a 0-100 scale. Higher scores indicate better health-related quality of life.","ALL","12 Years","17 Years",{"inclusion":73,"exclusion":80,"raw_text":94},[74,75,76,77,78,79],"Age 12-17 years old","Diagnosis of spastic cerebral palsy","Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening)","Jebsen Taylor Hand Function Test Score of \\\u003C37.08 on the affected side at time of screening visit (will be evaluated at screening)","Ability to communicate and follow two step commands at the time of screening","Ability to provide assent as detailed in consent form and based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent",[81,82,83,84,85,86,87,88,89,90,91,92,93],"Previous vagus nerve injury","Less than 12 years old or greater than 18 years old","History of left or bilateral vagotomy","Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc.","Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following:","Acute suicidal thinking or behavior","History of schizophrenia, schizoaffective disorder, or delusional disorders","History of rapid cycling bipolar disorder","Progressive neurological diseases","Cardiac arrhythmias or other abnormalities","History of dysautonomia including but not limited to orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope etc.","GMFCS score of less than II or greater than III (will be evaluated at screening)","Jebsen Taylor Hand Function Test Score of \\>37.08 on the affected side at time of screening visit (will be evaluated at screening)","Inclusion criteria:\n\n* Age 12-17 years old\n* Diagnosis of spastic cerebral palsy\n* Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening)\n* Jebsen Taylor Hand Function Test Score of \\\u003C37.08 on the affected side at time of screening visit (will be evaluated at screening)\n* Ability to communicate and follow two step commands at the time of screening\n* Ability to provide assent as detailed in consent form and based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent\n\nExclusion criteria:\n\n* Previous vagus nerve injury\n* Less than 12 years old or greater than 18 years old\n* History of left or bilateral vagotomy\n* Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc.\n* Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following:\n\n  * Acute suicidal thinking or behavior\n  * History of schizophrenia, schizoaffective disorder, or delusional disorders\n  * History of rapid cycling bipolar disorder\n  * Progressive neurological diseases\n  * Cardiac arrhythmias or other abnormalities\n  * History of dysautonomia including but not limited to orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope etc.\n* GMFCS score of less than II or greater than III (will be evaluated at screening)\n* Jebsen Taylor Hand Function Test Score of \\>37.08 on the affected side at time of screening visit (will be evaluated at screening)",[96],"CHILD",[98],{"facility":99,"status":8,"city":100,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":112},"The Charles Lazarus Children's Abilities Center","New York","10029","United States",[104,109],{"name":105,"role":106,"phone":107,"email":108},"Jenna Tosto Mancuso, PT, DPT,NCS","CONTACT","212-241-8454","jenna.tosto@mountsinai.org",{"name":110,"role":111},"David Putrino","PRINCIPAL_INVESTIGATOR",{"lat":113,"lon":114},40.71427,-74.00597,[116],{"name":105,"role":106,"phone":107,"email":108},[118],{"name":119,"affiliation":13,"role":111},"David Putrino, PhD",[],[],{"nct_id":4,"conditions":123,"biomarkers":124},[19],[],{"nct_id":4,"found":126,"summary":127,"prompt_version":137},true,{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an open-label study, meaning everyone knows what treatment is being given. It's a small study, planning to include 10 participants.","completed","Paired Non-invasive VNS for Adolescent Cerebral Palsy","This study is testing a new way to help adolescents (ages 12-17) with spastic cerebral palsy improve their arm and hand movement. It combines a device called non-invasive taVNS (transcutaneous auricular Vagus Nerve Stimulation), which activates a nerve through the ear using a mobile app, with upper body rehabilitation. The main goal is to see if this treatment is safe and practical, by tracking any side effects over 12 months. You might be able to join if you have spastic cerebral palsy, can follow two-step commands, and meet specific criteria for your motor function. This is a small study, planning to enroll 10 participants, and is currently unclear on its recruitment status.","Your safety will be monitored for 12 months after the treatment.",112,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]