[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566714":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":37,"locations":47,"responsibleParty":64,"collaborators":36,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":36,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":36,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":50,"whyStopped":36,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-surgical intervention group (PREG)","ACTIVE_COMPARATOR","Participants in the Pre-surgical intervention group (PREG) will undergo active rTMS 15 days before surgery. The protocol will be intermittent theta-burst (iTBS), with 3 pulses applied at 50Hz and modulated at 5Hz for 2s, repeated every 10s for a total of 120s, totaling 300 pulses, with intensity at 80% of the MRL. The stimulated targets will be the left and right posterior parietal cortex (P3 and P4) and the left and right dorsolateral prefrontal cortex (F3 and F4), totaling 1200 pulses per day",[13],"Other: Theta Burst Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Pre-surgical Control Group (PRECG)","SHAM_COMPARATOR","Participants in the Pre-surgical Control Group (PRECG) will undergo simulated rTMS with a 90º coil tilt with the lower part facing the scalp 15 days before surgery. The protocol will be intermittent theta-burst (iTBS), with 3 pulses applied at 50Hz and modulated at 5Hz for 2s, repeated every 10s for a total of 120s, totaling 300 pulses, with intensity at 80% of the MRL. The stimulated targets will be the left and right posterior parietal cortex (P3 and P4) and left and right dorsolateral prefrontal cortex (F3 and F4), totaling 1200 pulses per day.",[19],"Other: Theta Burst Stimulation Sham",{"label":21,"type":10,"description":22,"interventionNames":23},"Non-surgical Control Intervention Group (COG)","Participants in the Non-Surgical Control Intervention Group (COG) will undergo active rTMS. The protocol will be intermittent theta-burst (iTBS), with 3 pulses applied at 50Hz and modulated at 5Hz for 2s, repeated every 10s for a total of 120s, totaling 300 pulses, with intensity at 80% of the MRL. The stimulated targets will be the left and right posterior parietal cortex (P3 and P4) and the left and right dorsolateral prefrontal cortex (F3 and F4), totaling 1200 pulses per day",[13],[25,31],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Theta Burst Stimulation","Transcranial Magnetic Stimulation (TMS): A non-invasive brain stimulation (NIBS) technique that involves modulating brain excitability and activity, which can increase or decrease depending on the parameters used. Theta Burst Stimulation (TBS) mimics the brain's natural firing patterns more closely and may have greater effects on cognitive performance.",[21,9],[30],"Protocol",{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Theta Burst Stimulation Sham","Theta Burst Stimulation simulated with 90º coil orientation with lower part external to the scalp.",[15],[30],null,[38,43],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"Deise Ferreira, MSc","CONTACT","+55 11 98032-0345","deise.fsilva@hc.fm.usp.br",{"name":44,"role":40,"phone":45,"phoneExt":36,"email":46},"Clarice Tanaka, PhD","+55 11 2661-6175","cltanaka@usp.br",[48],{"facility":49,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"University of Sao Paulo","RECRUITING","São Paulo","01246903","Brazil","BR",{"type":56,"coordinates":57},"Point",[58,59],-46.63611,-23.5475,{"lat":59,"lon":58},[62,63],{"name":44,"role":40,"phone":45,"phoneExt":36,"email":46},{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Clarice Tanaka","Director of Physiotherapy Division","100566714","use-of-transcranial-magnetic-stimulation-in-the-post-operative-cognitive-dysfunction-in-elderly-100566714",false,"NCT06658769","Use of Transcranial Magnetic Stimulation in the Post-Operative Cognitive Dysfunction in Elderly","Use of Transcranial Magnetic Stimulation in the Prevention of Post-Operative Cognitive Dysfunction in Elderly with Mild Neurocognitive Disorder","Inclusion Criteria:\n\n1. Patients over 60 years old\n2. Patients scheduled for elective surgeries of moderate or large scale and candidates for general or spinal anesthesia;\n3. Patients who demonstrate possible or probable cognitive impairment based on pre-operative screening using the 10-CS (10-point cognitive screening) tool; - For Non-surgical Control Intervention Group, only the first and third criteria will be applied.\n\nExclusion Criteria:\n\n1. Contraindications for the use of Transcranial Magnetic Stimulation (metal implants in the head, history of seizures or epilepsy, brain trauma or surgery, intracranial hypertension, and complications from exposure to magnetic fields);\n2. Medical diagnosis of Major Neurocognitive Disorder (any form of dementia, regardless of the stage);\n3. Indication for skull surgery;\n4. Conditions that interfere with cognitive testing (presence of severe hearing and vision loss, inability to understand Portuguese);\n5. Ongoing medication adjustments that affect cortical electrical activity (antidepressants, antipsychotics);\n6. Difficulty attending treatment during the stipulated evaluation and follow-up period, whether due to socioeconomic or clinical reasons;\n7. Anticipation of surgical scheduling;","ALL","60 Years","120 Years",{"count":79,"type":80},12,"ESTIMATED","INTERVENTIONAL",[83],"NA","Postoperative Cognitive Dysfunction (POCD) is a prevalent condition with significant clinical, social, and financial impacts on patients and healthcare services. The term POCD refers to any signs of new cognitive impairment that exceed the expected time for recovery from the acute effects of surgery and anesthesia. Mild Cognitive Impairment (MCI) is among the main risk factors and is defined as a small cognitive decline from the previous level of performance in one or more cognitive domains, without interfering with daily activities. Considering the aging population linked to an increase in the number of individuals with MCI and a growing demand for surgery, the identification of interventions that can prevent the occurrence of POCD is necessary. Non-invasive brain stimulation (NIBS) techniques such as TMS (Transcranial Magnetic Stimulation) are widely used in research and clinical practice and involve the modulation of excitability and brain activity, potentially improving the individual's cognitive performance. The aim of this study is to assess the efficacy of a Theta Burst rTMS protocol with few sessions in preventing postoperative cognitive dysfunction in elderly individuals with mild neurocognitive disorder. Methodology: This will be a randomized, blinded clinical trial with volunteers aged \\> 60 years, candidates for elective surgeries, who will be randomly allocated into 2 groups: the groups will receive real or sham TBS 15 days before surgery. There will be 3 intervention sessions, with a 72-hour interval between them. Outcome measures will be cognitive psychological assessment and Stroop Test cognitive task performance before and after transcranial magnetic stimulation, after surgery and at the 3-month follow-up. There will be a non-surgical control group with cognitive impairment according to the study inclusion criteria and will receive active stimulation.",[86],"Postoperative Cognitive Dysfunction",[88,86,26],"Transcranial Magnetic Stimulation","2024-10-23",{"date":91,"type":92},"2024-10-26","ACTUAL",{"date":94,"type":92},"2024-04-01",{"date":96,"type":80},"2026-12-31",{"name":5,"class":6},1]