[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454544":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Universitat de Lleida","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"rTMS + neurorehabilitation","EXPERIMENTAL",null,[13,14],"Device: repetitive Transcranial Magnetic Stimulation","Device: sham repetitive Transcranial Magnetic Stimulation",{"label":16,"type":17,"description":11,"interventionNames":18},"sham rTMS + neurorehabilitation","SHAM_COMPARATOR",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","repetitive Transcranial Magnetic Stimulation","To apply the rTMS will be used the device Neuro-MS\u002FD Variant-3 therapeutic advanced (Neurosoft, Russia) with double cone shape coil. The coil will be placed at Cz according to 10-20 system.\n\nThe rTMS protocol will be:\n\nTrain frequency - 10 Hz Train duration - 10 sec Inter train interval - 50 seconds Number of train - 25\n\n\\------------------------------------- Total pulses - 2500 Total session duration - 1500 seconds",[9,16],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"sham repetitive Transcranial Magnetic Stimulation","Neuro-MS\u002FD magnetic stimulator (Neurosoft, Russia) with Neuro-MS.NET software will be used. The synchronous sound will be performed using monitor speaker connected to magnetic stimulator via trigger unit and located near discharging coil. The 10-Hz electrical stimulation will be given trough electrodes fixed on the head along the front edge of the coil to mimic the sensation",[9,16],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"CLAUDIA ARUMI, Msc","CONTACT","34+630-00-47-67","claudia.arumi@udl.cat",[36],{"facility":37,"status":11,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":11},"Claudia Arumi","Lleida","25006","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],0.62218,41.61674,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Clàudia Arumí","Principal Investigator","100454544","the-effectiveness-of-repetitive-transcranial-magnetic-stimulation-for-spastic-diplegia-cerebral-palsy-100454544",false,"NCT05198921","The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Spastic Diplegia Cerebral Palsy","The Effectiveness of Repetitive Transcranial Magnetic Stimulation for the Treatment of Spastic Diplegia Cerebral Palsy Based on the Gross Motor Function in School-aged Children: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Primary school children with diagnose of Spastic Diplegia CP\n* \\> 1 on Mas in hip flexors, adductors and tibialis anterior of both lower extremities.\n* Parents\u002Flegal guardians signed the Informed consent\n\nExclusion Criteria:\n\n* Severe mental retardation\n* Present epilepsy\n* Present any remedial surgery\u002Fmedication\n* Less than 1 year post orthopaedic surgery\n* Less than 6 months post botulinum toxin type A injection\n* Present metallic implants\n* Present any comorbidity unfit for the study\n* Congenital disorders such as Down's syndrome, fragile-x syndrome or congenital anomalies","ALL","6 Years","12 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","Cerebral palsy describes a group of permanent disorders of the development of movement and posture, causing activity limitation that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.\n\nNowadays, CP is not fully curable, and physiotherapy should be used in conjunction with other interventions such as oral drugs, botulinum toxin type A, continuous pump-administered intrathecal baclofen, orthopaedic surgery and selective dorsal rhizotomy. However, several systematic reviews conclude that there is low evidence that these invasive therapies are more effective than placebo.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a type of neuromodulatory technique through magnetic impulses. The effect of rTMS depends on the frequency of the emitted electromagnetic field; low frequencies (≤1 Hz) lead to an inhibition of neuronal electrical activity at the stimulation site, while high frequencies (≥3 Hz) cause neuronal depolarization.\n\nThe objective of the project is to evaluate the effectiveness of a repetitive Transcranial Magnetic Stimulation (rTMS) protocol, as an adjunct treatment to neurorehabilitation to improve gross motor function and quality of life in school-age children with spastic diplegia-type infantile cerebral palsy.",[70],"Cerebral Palsy, Spastic","NOT_YET_RECRUITING","2024-09-13",{"date":74,"type":75},"2024-09-19","ACTUAL",{"date":77,"type":64},"2025-01",{"date":79,"type":64},"2025-06",{"name":5,"class":6},1]