[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522440":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":39,"locations":45,"responsibleParty":69,"collaborators":30,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":30,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":48,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham Stimultion Group","SHAM_COMPARATOR","Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation group.",[13],"Device: Sham Transcranial magnetic stimulationt",{"label":15,"type":16,"description":17,"interventionNames":18},"Pre-ileostomy-closure Stimultion Group","ACTIVE_COMPARATOR","Patients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.",[19],"Device: Transcranial magnetic stimulation",{"label":21,"type":16,"description":22,"interventionNames":23},"Post-ileostomy-closure Stimultion Group","Patients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.",[19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Transcranial magnetic stimulation","The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla.Stimulation group: Intermittentpulse transcranial magnetic stimulation (iTBS) will be performed with : the cluster consists of 3 pulses, the intra-cluster frequency is 50Hz, the intercluster frequency is 5Hz, the interval is 8.2s for every stimulus. There are 20 cycles and a total of 600 pulses. Each intervention time is 3min11s, and the stimulation intensity is set as 80% resting state motion threshold. The intervention will be performed once a day for 2 weeks.",[21,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Sham Transcranial magnetic stimulationt","The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla. Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation group.",[9],[36],{"name":37,"affiliation":5,"role":38},"Jianbin Xiang, PhD","STUDY_CHAIR",[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Ying Mao, PhD","CONTACT","8621-52889999","Maoying@huashan.cn",[46],{"facility":47,"status":48,"city":49,"state":30,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Huashan Hospital Affiliated to Fudan University","RECRUITING","Shanghai","200040","China","CN",{"type":54,"coordinates":55},"Point",[56,57],121.45806,31.22222,{"lat":57,"lon":56},[60,64,67],{"name":61,"role":42,"phone":62,"phoneExt":30,"email":63},"Jianbin Xiang, doctor","86-21-52887040","68875417@qq.com",{"name":65,"role":42,"phone":62,"phoneExt":30,"email":66},"Minwei Zhou, doctor","zmwf1@126.com",{"name":61,"role":68,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Jianbin Xiang","Professor，Ph.D., M.D.","100522440","study-of-brain-gut-function-reconstruction-after-intersphincteric-resection-for-ultra-low-rectal-tumors-100522440",false,"NCT06082648","Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors","Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors","Inclusion Criteria:\n\n* Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.\n* Patient who is willing to participate in the study, and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Anastomotic leakage or other serious complications occur after surgery.\n* Advanced tumor, tumor recurrence or metastasis.\n* Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.\n* Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.\n* Combined with organic brain disease and drug abuse history.\n* Combined with other mental diseases.\n* Pregnant or lactating women.",true,"ALL","18 Years","75 Years",{"count":84,"type":85},57,"ESTIMATED","INTERVENTIONAL",[88],"NA","To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the \"new\" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.",[91],"Rectal Neoplasms",[93,94,95,96],"Ultra-low rectal tumors","Intersphincteric Resection","transcranial magnetic stimulation","fMRI","2023-10-07",{"date":99,"type":100},"2023-10-13","ACTUAL",{"date":102,"type":100},"2023-06-01",{"date":104,"type":85},"2026-10-30",{"name":5,"class":6},1]