[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"visual-evoked-potential-monitoring\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:visual-evoked-potential-monitoring":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100653600","intraoperative-neurophysiological-monitoring-in-brain-tumor-surgery-prospective-cohort-studies-100653600",false,"NCT07789938","Intraoperative Neurophysiological Monitoring in Brain Tumor Surgery: Prospective Cohort Studies","Intraoperative Monitoring of Motor, Visual and Cortico-cortical Evoked Potentials in Brain Tumor Surgery Under General Anesthesia: Prospective Cohort Studies","Part 1 is a litterature review.\n\nPart 2 - Inclusion Criteria:\n\n1. Patient age ≥ 18 years and ability to provide informed consent;\n2. Planned resection of ≥ 1 contrast-enhancing brain tumors (tentative diagnosis high-grade glioma or metastasis) on magnetic resonance imaging (MRI) in either general anesthesia or asleep-awake-asleep setting;\n3. Intended gross total or complete tumor resection;\n4. Tumor located \\\u003C 10 mm from the language areas (Broca's or Wernicke's) or subcortical language tracts (AF or SLF);\n5. Tumor located in a language-dominant hemisphere;\n6. Written informed consent.\n\nPart 2 - Exclusion Criteria:\n\n1. Tumors directly involving Broca's or Wernicke's area;\n2. Pregnancy;\n3. Emergency surgery;\n4. Tumors involving both hemispheres.\n\nPart 3 - Inclusion Criteria:\n\n1. Patient age ≥ 18 years and ability to provide informed consent;\n2. Planned resection of ≥ 1 contrast enhancing brain tumors (tentative diagnosis high-grade glioma or metastasis) on MRI in general anesthesia setting;\n3. Intended gross total or complete tumor resection;\n4. Tumor located \\\u003C 20 mm from the precentral gyrus or CST;\n5. Written informed consent.\n\nPart 3 - Exclusion Criteria:\n\n1. Tumors directly involving the precentral gyrus or CST;\n2. Pregnancy;\n3. Emergency surgery;\n4. Recurrent brain tumor surgery;\n5. Tumors involving both hemispheres.\n\nPart 4 - Inclusion Criteria:\n\n1. Patient age ≥ 18 years and ability to provide informed consent;\n2. Planned resection of ≥ 1 contrast enhancing pituitary tumors (tentative diagnosis adenoma), contrast enhancing brain tumors (tentative diagnosis high-grade glioma, metastasis or meningioma), or non-enhancing brain tumors (tentative diagnosis low-grade glioma) on MRI in general anesthesia setting;\n3. Intended gross total or complete tumor resection;\n4. Tumor located \\\u003C 10 mm from, or involving, the anterior or posterior visual pathways;\n5. Written informed consent.\n\nPart 4 - Exclusion Criteria:\n\n1. Pregnancy;\n2. Emergency surgery;\n3. Severe visual impairment precluding reliable VEP monitoring (typically best-corrected visual acuity ≤ 0.2-0.4 on the Snellen scale).","ALL","18 Years",{"count":19,"type":20},166,"ESTIMATED","INTERVENTIONAL",[23],"NA","BACKGROUND Brain tumor surgery requires balancing two competing priorities: maximizing the extent of tumor resection to improve survival while preserving neurological function. This is particularly challenging in eloquent brain tumor surgery, where even minor injury may result in permanent loss of functions such as muscle paralysis, language impairment, or visual loss, substantially affecting patients' independence and quality of life.\n\nIntraoperative neurophysiological monitoring (IOM) combines functional mapping to identify eloquent structures with continuous monitoring of the integrity of eloquent structures during tumor resection. IOM with motor evoked potentials (MEP) is widely used to map and monitor motor-eloquent structurse but still lack high-quality evidence demonstrating patient-related benefit. Other modalities, including cortico-cortical evoked potentials (CCEP) for language monitoring and visual evoked potentials (VEP) for visual pathway monitoring, are promising but lack standardization and further clinical validation.\n\nAIM To strenghten the evidence base and clinical application of IOM in eloquent brain tumor surgery, enabling safer and more effective surgical treatment.\n\nHYPOTHESES\n\nThe project is based on the following hypotheses:\n\n1. CCEP monitoring lacks standardization and clinical validation, and its use varies considerably across clinical practice.\n2. Intraoperative CCEP signal changes are associated with postoperative language impairment and can be used to establish clinically relevant warning thresholds.\n3. IOM with MEP improves motor function preservation and\u002For increases the extent of safe tumor resection compared with surgery without IOM.\n4. Intraoperative VEP signal changes are associated with postoperative visual impairment and can be used to establish clinically relevant warning thresholds.\n\nPROJECT DESIGN The project comprises four unprecedented studies. Part 1 is a scoping review on CCEP monitoring to evaluate current clinical practice and evidence gaps.\n\nPart 2 is a prospective observational cohort study including adult patients undergoing resection of language-eloquent brain tumors in either general anesthesia or asleep-awake-asleep setting which evaluates the association between intraoperative CCEP signal changes and postoperative language impairment, and explores clinically relevant warning thresholds.\n\nPart 3 is a randomized controlled trial in adult patients undergoing resection of motor-eloquent brain tumors which compares surgery performed using IOM with MEP versus no IOM to evaluate its effect on postoperative motor function and extent of tumor resection.\n\nPart 4 is a prospective observational cohort study including adult patients undergoing visual-eloquent transsphenoidal or transcranial surgery for tumors involving the visual pathways. It evaluates the association between intraoperative VEP signal changes and postoperative visual impairment, and explores clinically relevant warning thresholds.\n\nStandardized clinical assessments, advanced neuroimaging, and appropriate statistical analyses will be used for this purpose.\n\nLIMITATIONS Variability between patients, tumor characteristics, and surgical procedures may complicate interpretation of intraoperative signals. In particular, VEP recordings may be affected by physiological and technical variability. Furthermore, ethical and safety considerations mean that not all patients will be eligible for every part of the project.\n\nEXPECTED OUTCOME AND IMPACT Brain tumors are associated with substantial morbidity, permanent loss of function, and mortality. Even modest improvements in functional preservation and the extent of safe tumor resection may significantly improve survival, independence, quality of life, and return to daily activities.\n\nThe project is expected to generate unprecedented clinical evidence on IOM in eloquent brain tumor surgery through the first randomized controlled trial evaluating the patient-related benefits of IOM with MEP, and the first prospective studies on CCEP monitoring in awake and general anesthesia setting and VEP monitoring of the entire visual pathway. By addressing major evidence gaps, the project will strengthen the evidence base for IOM, improve interpretation of IOM signals and surgical decision-making, and support rapid implementation into clinical practice locally as well as impacting the use of IOM world wide.\n\nUltimately, the project is expected to enable safer and more effective brain tumor surgery with a lower risk of permanent motor, language, and visual impairment, improved survival and quality of life, and reduced need for rehabilitation and supportive care, thereby improving patient safety and enabling more precise and effective surgical treatment.\n\nFurthermore, the project is related to the 3rd United Nations sustainable development goal: \"Ensure healthy lives and promote well-being for all at all ages.\"",[26,27,28,29,30],"Intraoperative Neurophysiological Monitoring","Malignant Brain Tumors","Motor Evoked Potential Monitoring","Cortico-cortical Evoked Potential Monitoring","Visual Evoked Potential Monitoring",[32,33,34,35,36,37,38],"IOM","intraoperative neurophysiological monitoring","motor evoked potential","cortico-cortical evoked potential","visual evoked potential","intraoperative monitoring","IOM in brain tumor surgery","NOT_YET_RECRUITING","2026-08-24",{"date":42,"type":43},"2026-08-27","ACTUAL",{"date":45,"type":20},"2027-01-01",{"date":47,"type":20},"2029-12-31",{"name":49,"class":50},"Odense University Hospital","OTHER"]