[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564436":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":33,"overallOfficials":21,"centralContacts":39,"locations":21,"responsibleParty":45,"collaborators":21,"id":49,"slug":21,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":21,"enrollmentInfo":58,"targetDuration":21,"studyType":61,"phases":21,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":69,"whyStopped":21,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":21},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Correlation between eye movement parameters and SDMT.","Correlation between eye movement parameters (VDI AUC and VDI Pv\u002FAm, left and right) and SDMT scores in patients with MS.","baseline",[14,18],{"measure":15,"description":16,"timeFrame":17},"Number of patients with eye movement abnormalities assessed by infrared oculography","The number of patients with VDI AUC\\>1.174 and\u002For VDI Pv\u002FAm\\>1.180 assessed by infrared oculography during prosaccades at 15 degrees left or right.","Baseline",{"measure":19,"description":20,"timeFrame":17},"Correlation between eye movement parameters and cognitive test scores.","The cognitive tests used to asses this correlation include the following: the PASAT (Paced Auditory Serial Addition Task), the CVLT-II (California Verbal Learning Test-II) and the BVMT-R (Brief Visuospatial Memory Test Revised).\n\nThe correlation between eye movement parameters parameters (VDI Pv\u002FAm and VDI AUC, left and right), and cognitive test scores will be analyzed through Spearman correlation analysis.",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","CROSS_SECTIONAL","As previously described in the brief summary, this clinical study aims to investigate the relationship between cognitive impairment and eye movement parameters in Multiple Sclerosis (MS).\n\nCognitive tests\n\nCognitive impairment is a common symptom in patients with MS. The most affected cognitive domains are information processing speed and visual memory, but also the domains of attention, executive function, working memory, visuospatial processing and verbal memory can be affected. There are different valid screening and evaluation tools for cognitive impairment (CI) described and used in the MS field. This clinical study will use the tests of the Brief International Cognitive Assessment for MS (BICAMS).\n\nInfrared oculography\n\nAnother common symptom in MS is problems with eye movements. An eye condition commonly seen in these patients is internuclear ophthalmoplegia (INO). It is a specific conjugate horizontal gaze disorder characterized by slowed movement of the adducting eye relative to the abducting eye in horizontal saccades, resulting from damage to the medial longitudinal fasciculus (MLF). This may lead to (transient) diplopia or 'blurring of vision', particularly during horizontal gaze. INO can be diagnosed by using infrared oculography, a noninvasive method of quantifying eye movements. Recent research indicates that eye movements can reflect certain aspects of brain function and provide insights into cognitive impairments. Therefore, this study aims to investigate the prevalence of INO in MS using infrared oculography, compare the diagnosis of INO using infrared oculography with clinical examination by a physician and lastly explore the relationship between the presence of INO and cognitive decline.\n\nInvestigational plan\n\nThe study will be a prospective observational multi-center, cross-sectional cohort study.\n\nPatients will be recruited at the National MS Center Melsbroek (NMSC) in close collaboration with Prof. Miguel D'haeseleer (Neurology), Prof. Daphne Kos (Rehabilitation and research coordinator) and Mieke D'hooge (Neuropsychologist). At any moment in time about 80 MS patients are in a short rehabilitation admission at the National MS Centre Melsbroek. Additionally, patients will be recruited from the MS department in the neurology wing of UZ Brussels. The MS team at UZ Brussel comprises Prof. Dr. Ir. Guy Nagels (Head of Departement), Prof. Dr. Miguel D'Haeseleer, Prof. Dr. Marie D'Hooghe, Dr. Stéphanie Hostenbach, and Annick Van Merhaegen.\n\nWhen patients fulfill the inclusion criteria and give active informed consent, they will be contacted by phone to schedule their visit. If patients would like more information they can contact the investigator by phone.\n\nDuring their visit, patients will undergo cognitive testing and infrared oculography. The investigators will start with the cognitive assessments, which include the BICAMS and the PASAT. The BICAMS is a 15-minute-long neuropsychological evaluation battery (9). The PASAT typically lasts 15-20 minutes. Altogether, the cognitive testing will take around 40 minutes. Following this, the infrared oculography measurements will be done. According to a study that provided a standardized and reproducible protocol for infrared oculography measurements, the total experiment duration was 21 minutes, excluding instructions. Thus, the oculography process will take roughly 30 minutes. To ensure enough time for each patient and avoid rushing, the total duration of the visit will be approximately 1,5 hours per patient.\n\nAfter their first visit, there is no need for a follow-up. Should any questions arise afterward, they are welcome to reach out to us via phone or email.\n\nPatients may withdraw from the study at any time for any reason.\n\nQuality assurance plan\u002F data checks\n\nAfter measurement, the variables that are needed for analysis have to be imported into Matlab. The analysis will be automated and checked for quality issues by researchers. To pass quality control, at least 50% of prosaccades at 15 degrees must be captured.\n\nSource data verification To ensure accuracy and completeness, two researchers will evaluate and verify the source data. Any discrepancies will be documented and managed in line with the Good Clinical Practice guidelines.\n\nData dictionary\n\nINO will be quantified through eye movement parameters Cognitive scores will be recorded.\n\nClinical parameters that will be recorded:\n\n* EDSS score, a numeric value between 0 and 10\n* Age, a numeric value \\> 18\n* Disease duration, a numeric value (years)\n* Sex, female or male\n\nStandard Operating Procedures (SOPs)\n\nOnly the investigators will be responsible for data entry. As previously described, the analysis will be automated and checked for quality issues by researchers.\n\nAll data will be collected, encrypted, analyzed and stored on a dedicated sharepoint using the One Drive cloud service provided by the VUB, secured by password protection. All files from this server will be removed 5 years after the end of publication of the research results.\n\nSample size assessment\n\nThe investigators will use a one-tailed alpha of 0.05 (as the hypothesis is that worse visual scanning will relate to worse cognitive scores), a power of 0.8 (0.2 Type II error rate), and a correlation coefficient of 0.4 - corresponding to 16% of the variance of the SDMT being explained by eyesight - which leads to a sample size of 37. To be on the safe side and to account for possible data quality issues, the investigators will recruit N = 50 patients in this study.\n\nPlan for missing data\n\nIn the exceptional case that some parameters are missing for some patients, those patients will be excluded from the specific analyses for which these datapoints are needed.\n\nStatistical analyses plan\n\nThe correlation between eye movement parameters (VDI Pv\u002FAm and VDI AUC, left and right), and cognitive test scores will be analyzed through Spearman correlation analysis.","MS patients recruited from the neurology department of UZ Brussels and NMSC Melsbroek in Belgium",[28],{"label":29,"type":21,"description":30,"interventionNames":31},"People with multiple sclerosis","This study will include 50 people with MS (see in\u002Fexclusion criteria under \"Eligibility\").",[32],"Diagnostic Test: Infrared oculography",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":21},"DIAGNOSTIC_TEST","Infrared oculography","Eye movements will be captured through infrared oculography and processed via in-house algorithms.",[29],[40],{"name":41,"role":42,"phone":43,"phoneExt":21,"email":44},"Jeroen Van Schependom, PhD in Medical Sciences","CONTACT","0032 6291040","jeroen.van.schependom@vub.be",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Jeroen Van Schependom","Research Professor","100564436",false,"NCT06629155","Studying Eye Movement Deficits and Cognitive Impairment in Patients with Multiple Sclerosis Using Infrared Eye Tracking and Cognitive Tests","Disentangling Cognitive Functioning and Visual Scanning Deficits in Cognitive Test Results in Multiple Sclerosis (MS)","VisuMS","Inclusion criteria:\n\n* Diagnosed with clinically definite multiple sclerosis according to the 2017 McDonald criteria\n* At least 18 years old\n* Combined vision with optimal correction \\> 0,6 on Snellen Visual Acuity Test.\n* Providing informed consent.\n\nExclusion criteria:\n\n* Major medical or psychiatric pathology that potentially affects cognitive functioning.\n* A score higher than 63 on the Fatigue Scale for Motor and Cognitive Functions is categorized as severe fatigue\n* Start or switch in immunomodulatory treatment within three months before inclusion.\n* Less than 3 months post exacerbation.\n* Refusing informed consent.","ALL","18 Years",{"count":59,"type":60},50,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to study the relationship between cognitive problems and problems in eye movements in Multiple Sclerosis (MS).\n\nThe main questions it aims to answer are:\n\n* What is the correlation between eye movement parameters (VDI AUC and VDI Pv\u002FAm, left and right) and SDMT scores in patients with MS?\n* What is the number of patients with VDI AUC\\>1.174 and\u002For VDI Pv\u002FAm\\>1.180 assessed by infrared oculography during prosaccades at 15 degrees left or right?\n* What is the correlation between eye movement parameters (VDI AUC and VDI Pv\u002FAm, left and right) and cognitive test scores in patients with MS?\n\nParticipants will perform specific cognitive tests and eye movements will be measured through infrared oculography.\n\nThe primary hypothesis for the study is: participants who exceed the treshold (VDI AUC\\>1.174 and\u002For VDI Pv\u002FAm\\>1.180, left or right) will perform worse on cognitive tests compared to those who don't.",[64,65],"Multiple Sclerosis","Internuclear Ophthalmoplegia",[67,64,65,68],"Cognitive impairment","SDMT","NOT_YET_RECRUITING","2024-11-04",{"date":72,"type":73},"2024-11-06","ACTUAL",{"date":75,"type":60},"2025-03-01",{"date":77,"type":60},"2027-02-01",{"name":5,"class":6}]