[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586911":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":31,"locations":39,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":17,"eligibilityCriteria":80,"healthyVolunteers":77,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":17,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":42,"whyStopped":17,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"KK Women's and Children's Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention: Standard care + AscenZ-IV Stimulation","EXPERIMENTAL","Participants randomized as Group 1 first receive both standard care (existing medical interventions, therapy program) and AscenZ-IV Stimulation for 8 weeks (30min\u002Fday; 5 to 7 sessions\u002Fweek, additional 30min\u002Fday; 5 to 7 sessions\u002Fweek for behavioral and drooling issues if necessary). Then, they receive standard care only for another 8 weeks. For participants randomized as Group 2, control condition precedes intervention condition. Subsequently, participants are given the option to receive an additional 4 weeks of intervention for maintenance",[13],"Device: AscenZ-IV neuromodulation device",{"label":15,"type":16,"description":11,"interventionNames":17},"Control: Standard care only","NO_INTERVENTION",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"DEVICE","AscenZ-IV neuromodulation device","AscenZ-IV neuromodulation device is a novel treatment modality that utilizes 2 non-invasive neuromodulation technologies - tPCS and TENS - concurrently within a device. The home-based, non-invasive AscenZ-IV Stimulator therapy has been shown to improve spasticity and motor function",[9],[25,28],{"name":26,"affiliation":5,"role":27},"Zhi Min Ng, MBBS, MRCPCH","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Jeremy Lin, MBBS, MRCPCH","National University Hospital, Singapore",[32,36],{"name":26,"role":33,"phone":34,"phoneExt":17,"email":35},"CONTACT","+65 62255554","ng.zhi.min@singhealth.com.sg",{"name":29,"role":33,"phone":37,"phoneExt":17,"email":38},"+65 69082222","jeremy_lin@nuhs.edu.sg",[40,57],{"facility":41,"status":42,"city":43,"state":17,"zip":44,"country":43,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"National University Hospital Singapore","RECRUITING","Singapore","119074","SG",{"type":47,"coordinates":48},"Point",[49,50],103.85007,1.28967,{"lat":50,"lon":49},[53,54,56],{"name":29,"role":33,"phone":37,"phoneExt":17,"email":38},{"name":55,"role":33,"phone":17,"phoneExt":17,"email":17},"Kyu Eon Jeon",{"name":29,"role":27,"phone":17,"phoneExt":17,"email":17},{"facility":5,"status":42,"city":43,"state":17,"zip":58,"country":43,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"229899",{"type":47,"coordinates":60},[49,50],{"lat":50,"lon":49},[63,64,68],{"name":26,"role":33,"phone":34,"phoneExt":17,"email":35},{"name":65,"role":33,"phone":66,"phoneExt":17,"email":67},"Ting Wei Ng, Bsc (hons) Biomedical Science","+65 88904755","ng.ting.wei@kkh.com.sg",{"name":26,"role":27,"phone":17,"phoneExt":17,"email":17},{"type":27,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Ng Zhi Min","Principal Investigator",[73],{"name":30,"class":74},"OTHER","100586911","a-novel-home-based-non-invasive-neuromodulation-therapy-for-children-and-adolescents-with-cerebral-palsy-100586911",false,"NCT06921538","A Novel Home-based Non-invasive Neuromodulation Therapy for Children and Adolescents With Cerebral Palsy","Inclusion Criteria:\n\nChildren and adolescents aged between 2 to \\\u003C21 years old with mild to severe Spastic Cerebral Palsy (CP) classified on Gross Motor Function Classification System (GMFCS) II, III, IV, V. Families with at least one parent or caregiver has simple or conversational English language skill.\n\nTo be eligible for the qualitative interview components of this research study, the individuals should be recognised as one of the following:\n\n1. CP patients who participate in this research study,\n2. caregivers of the CP patients taking part in this research study,\n3. implementation staff\n4. qualified clinicians not involved in the intervention or refused to recommend the intervention device (AscenZion-IV stimulator) for management of CP.\n\nEligible individuals must agree to be audio-recorded.\n\nExclusion Criteria:\n\n1. CP patients with epilepsy with recent seizures (\\<12 months) will be excluded for safety given the theoretical risks of seizures (abnormal brain electrical discharges) with transcranial electrical stimulation. We will include those with well controlled epilepsy with no recent seizures (within 12 months).\n2. CP patients who have contra-indications to the use of tPCS and\u002For TENS will be excluded from the study, include:\n\n   * Individuals with history of uncontrolled epileptic disorder, seizures, brain tumour or trauma, and mental disease\n   * Individuals with electrical implanted stimulatory device, such as pacemaker or defibrillator\n   * Individuals with medical devices that are affected by magnets, such as programmable shunts.\n   * Individuals with pregnancy\n3. CP patients who received any intramuscular botulinum toxin injections within less than 6 months (as anti-spasticity effect lasts for 4-6 months).\n4. CP patients who received any musculo-skeletal, brain or nerve-related surgery within less than 6 months, or major surgery requiring prolonged hospitalisation (\\>1week) within less than 3 months.\n\nThose who do not agree to be audio-recorded will be excluded for the qualitative interview components of this research study.","ALL","6 Years","21 Years",{"count":85,"type":86},60,"ESTIMATED","INTERVENTIONAL",[89],"NA","The aim of this study is to evaluate the clinical effectiveness, feasibility and acceptability of a novel home-based noninvasive neuromodulation therapy (AscenZ-IV Stimulator) that utilizes transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) for children and adolescents with cerebral palsy as a community-based intervention by families and healthcare providers.",[92],"Cerebral Palsy (CP)",[94],"neuromodulation","2025-04-08",{"date":97,"type":98},"2025-04-10","ACTUAL",{"date":100,"type":98},"2024-10-11",{"date":102,"type":86},"2025-11",{"name":5,"class":6},2]