[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626237":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":50,"centralContacts":54,"locations":64,"responsibleParty":80,"collaborators":49,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":49,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":49,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":66,"whyStopped":49,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"tSCS + Functional Activity Training","ACTIVE_COMPARATOR","Transcutaneous spinal cord stimulation will be paired with training based on Aim.\n\nParticipants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.\n\nParticipants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate.",[13,14],"Other: tSCS","Other: Functional Activity Training",{"label":16,"type":17,"description":18,"interventionNames":19},"tSCS + Functional Activity Training + 5-Azacitidine","EXPERIMENTAL","Transcutaneous spinal cord stimulation will be paired with training based on Aim.\n\nParticipants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.\n\nParticipants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate.\n\nA subset of opt-in participants will also be randomized to receive either 5-Azacitidine (VIDAZA) or placebo (Mannitol) at midpoint. A registered nurse will deliver a single subcutaneous injection of either AZA or placebo at a dose of 75 mg\u002Fm² to the participants lower abdomen or medial thigh.",[13,20,14],"Drug: 5-Azacitidine",{"label":22,"type":10,"description":18,"interventionNames":23},"tSCS + Functional Activity Training + Mannitol (Placebo)",[13,24,14],"Drug: Mannitol",[26,32,39,45],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"tSCS","Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment.",[9,16,22],[31],"Transcutaneous Spinal Stimulation",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","5-Azacitidine","A subset of opt-in participants will receive a single subcutaneous injection of 5-Azacitidine at a dose of 75 mg\u002Fm²",[16],[38],"VIDAZA",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Mannitol","A subset of opt-in participants will receive a single subcutaneous injection of Mannitol (placebo) at a dose of 75 mg\u002Fm².",[22],[44],"Placebo",{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Functional Activity Training","All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training.\n\nParticipants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training.",[9,16,22],null,[51],{"name":52,"affiliation":5,"role":53},"Arun Jayaraman, PhD","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":49,"email":59},"Audrey Wiesner, BS","CONTACT","3122388435","awiesner@sralab.org",{"name":61,"role":57,"phone":62,"phoneExt":49,"email":63},"Jacklyn Stoller, PT, DPT","3122387620","jstoller@sralab.org",[65],{"facility":5,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Chicago","Illinois","60611","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-87.65005,41.85003,{"lat":76,"lon":75},[79],{"name":52,"role":53,"phone":49,"phoneExt":49,"email":49},{"type":53,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Arun Jayaraman, PT, PhD","Scientific Chair, Technology & Innovation","100626237","phase-2-tscs-and-5-azacitidine-for-enhanced-motor-outcomes-in-cerebral-palsy-100626237",false,"NCT07433023","tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy","Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy","Inclusion Criteria:\n\n* Diagnosis of cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) Levels I-V.\n* Between 4 and 17 years old at the time of enrollment\u002Fconsent.\n* Diagnosis of spastic CP hemiplegia, diplegia, or quadriplegia.\n* Stable medical condition as determined by the investigator.\n* Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator.\n* Capable of performing simple cued motor tasks and can follow 2-3 step commands.\n* Capable of communicating an accurate yes or no answer to questions according to parent or guardian.\n* Able to localize pain\u002F discomfort.\n* Physician approval for participation.\n* Parent\u002F guardian permission.\n\nExclusion Criteria:\n\n* Concurrent neurological disease affecting the central nervous system.\n* Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention\n* Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the upper and\u002For lower extremity\n* Unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities\n* Implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant) or drug delivery device (e.g., baclofen pump)\n* Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker, implanted drug pump), ventilation support, or another external device.\n* History of uncontrolled seizures\n* Unexplained presence of persistent complaints of pain of any kind\n* Unable to localize pain\u002Fdiscomfort\n* Severe cortico-visual impairment\n* Active pressure sores\n* Active urinary tract infection\n* Active cancer or cancer in remission less than 5 years\n* Clinically significant depression, psychiatric disorders, or ongoing drug abuse\n* Immunodeficiency or hematologic condition\n* Allergy to AZA or mannitol\n* Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 10\n* Pregnancy\n* Orthopedic surgery completed in the prior 12 months\n* Intrathecal medication titration that may affect muscle spasticity\n* Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the treating physician\n* Current enrollment in a conflicting research study\n* Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the investigator or treating physician","ALL","4 Years","17 Years",{"count":94,"type":95},80,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","This is an intervention study to investigate the impact of spinal stimulation on mobility outcomes in children with Cerebral Palsy. Participants will complete a 16-week training program with weekly sessions of spinal stimulation and walking or activity-based training. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the spinal stimulation to further affect mobility outcomes.",[101],"Cerebral Palsy",[103,31],"Pediatric","2026-05-28",{"date":106,"type":107},"2026-05-29","ACTUAL",{"date":104,"type":107},{"date":110,"type":95},"2029-01-01",{"name":5,"class":6},1]