[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557324":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":42,"locations":50,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":9,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":23,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":53,"whyStopped":23,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SAES","EXPERIMENTAL","Treatment group (SAES)\n\nInterventions: Sensory afferent electrical stimulation (SAES)",[13],"Other: SAES",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and\u002For physiotherapy.",[18],"Other: TAU",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"The experimental intervention consists of SAES with a glove or adhesive electrodes at 20Hz, 300µs, intensity between 2-10mA, during 30 minutes per day, 5x\u002Fweek, for 5 weeks, combined with conventional occupation therapy. The subsequent therapy sessions will take place at home, with in-between telephone checks.",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"TAU","Treatment as usual",[15],[29,32,35,38,40],{"name":30,"affiliation":5,"role":31},"Regula Everts, Prof. Dr.","STUDY_CHAIR",{"name":33,"affiliation":5,"role":34},"Grunt Sebastian, Prof. Dr.","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":31},"Nef Tobias, Prof. Dr.","ARTORG",{"name":39,"affiliation":5,"role":31},"Wiest Roland, Prof. Dr.",{"name":41,"affiliation":5,"role":31},"Seidel Kathleen, Prof. Dr.",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":23,"email":47},"Alisa Gschaidmeier, Dr. med.","CONTACT","031 632 94 24","alisa.gschaidmeier@insel.ch",{"name":49,"role":45,"phone":46,"phoneExt":23,"email":23},"Sebastian Grunt, Prof. Dr.",[51],{"facility":52,"status":53,"city":54,"state":23,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Inselspital","RECRUITING","Bern","3010","Switzerland","CH",{"type":59,"coordinates":60},"Point",[61,62],7.44744,46.94809,{"lat":62,"lon":61},[65],{"name":49,"role":45,"phone":23,"phoneExt":23,"email":23},{"type":67,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[69],{"name":70,"class":6},"University of Bern","100557324","effects-and-mechanisms-of-sensory-afferent-electrostimulation-on-upper-limb-function-in-patients-with-hemiparesis-100557324",false,"NCT06536634","Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis","Inclusion Criteria:\n\n* Diagnosis of unilateral cerebral palsy\u002Fhemiparesis, following unilateral brain lesion, e.g. perinatal\u002Fchildhood stroke (acquired prior to the age of 16 years)\n* consistent and stable limitation of hand functions\n* chronic state (time since lesion \\>2 years)\n* aged 6-18 years\n* parental informed consent if \\\u003C14 years, informed consent of the patient if \\>14 years\n\nExclusion criteria:\n\n* psychiatric disease that prevents the participant form informed participation and compliance in an adequate manner\u002Fsetting\n* Bilateral brain lesion\n* Recent Botulinum toxin-injections injections (UL, \\\u003C 6 months)\n* Hand surgery on paretic hand \\\u003C 2 years\n* Trauma to UL in the last year\n* Medical conditions that prevent training of the UL\n* Participation in other afferent stimulation studies\n* Electrical stimulation therapy in the last 6 months\n* Intensive training of the UL (therapy more than 1x\u002Fweek, \\\u003C 6 months)\n\nIf MRI and TMS is performed, additionally:\n\n• MRI and TMS contradictions, such as\n\n* implanted Metal devices (e.g. braces, implant)\n* implanted shunt system\n* in girls and women: pregnancy\n* claustrophobia\n* Active epilepsy","ALL","6 Years","18 Years",{"count":81,"type":82},34,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal for this project is to investigate the effects of a 5-week SAES therapy in addition to conventional therapy on both behavioural (sensory and motor) and neurological measures and the underlying mechanisms of treatment response.\n\nThe goal of this project to investigate the effects of a 5-week SAES therapy in addition to conventional therapy.\n\nThe aim is to investigate whether SAES is more effective than conventional therapy alone in children with hemiparesis. The investigators will assess the efficacy of SAES using novel clinical assessment such as kinematic evaluations and modern neurophysiological measures, namely transcranial magnetic stimulation (TMS) and resting-state functional MRI (rs-fMRI).\n\nIt will be expected a benefit for children with hemiparesis after SAES training which may lead to improved bimanual and unimanual functions. Benefits have been reported in adults and in preliminary studies also in children.\n\nType of study: Randomised controlled clinical trial\n\nParticipants with hemiparesis will be included in the study. The study group will receive the SAES training with a glove or adhesive electrodes as a home-based training during 30 minutes per day, 5x\u002Fweek, for 5 weeks, combined with conventional occupation therapy.\n\nResearchers will compare the SAES group with a group of patients with comparable conditions who receive the prescribed conventional occupational therapy and\u002For physiotherapy (treatment as usual, TAU)",[88,89],"Hemiparesis","Unilateral Cerebral Palsy",[91,92,93,94,95,96],"Sensory afferent electrostimulation","MRI","TMS","Motor function","Sensory function","Sensor","2025-11-17",{"date":99,"type":100},"2025-11-20","ACTUAL",{"date":102,"type":100},"2025-01-01",{"date":104,"type":82},"2027-10-01",{"name":5,"class":6},1]