[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493300":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":34,"locations":42,"responsibleParty":69,"collaborators":24,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":98,"whyStopped":24,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Waitlist Group","EXPERIMENTAL","Those randomly assigned to the waitlist group will complete initial inclusion tests and baseline tests at Visit 1. They will receive no intervention during Period 1 (week 1-6) and then repeat baseline tests at Visit 2. Next they will perform the VR audiovisual stimulation during Period 2 (week 7-12) and then repeat baseline tests post-intervention at Visit 3.",[13],"Device: Audiovisual Stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"VR Intervention First","Those randomly assigned to the intervention-first group will complete initial inclusion tests and baseline tests at Visit 1. They will perform the VR audiovisual stimulation during Period 1 (week 1-6) and then repeat baseline tests at Visit 2. They will receive no intervention during Period 2 (week 7-12) and then repeat baseline tests at Visit 3.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Audiovisual Stimulation","The device application involves the 3D multiple-object-tracking (3D-MOT) paradigm composed of 8 high-contrast spheres which are adapted to the visual ability of participant (luminosity and size). The initial speed of the spheres is adjustable and determined during the inclusion visit.\n\nOne or more of the spheres is temporarily highlighted (target). Then all 8 spheres move for 20 seconds following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. After 20 seconds, the movement stops and the participant is asked to select, using the hand controller, the initially highlighted target(s) among the 8 spheres. If the selection is correct the speed of the spheres in the next trial is increased. If the selection is incorrect the speed of the spheres in the next trial is decreased.\n\nBased on performance, stimulations will be adjusted to change difficulty level (e.g. changing backgrounds, number of cued balls, etc.)",[15,9],null,[26,29,32],{"name":27,"affiliation":5,"role":28},"Michael Reber, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Lora Appel, PhD","York University",{"name":33,"affiliation":5,"role":28},"Jennifer Campos, PhD",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Danielle Tchao","CONTACT","647-408-9638","danielle.tchao@uhn.com",{"name":30,"role":37,"phone":24,"phoneExt":24,"email":41},"lora.appel@uhn.ca",[43,59],{"facility":44,"status":24,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"KITE Research Institute, UHN","Toronto","Ontario","M5G 2A2","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-79.39864,43.70643,{"lat":54,"lon":53},[57],{"name":33,"role":37,"phone":24,"phoneExt":24,"email":58},"jennifer.campos@uhn.ca",{"facility":60,"status":24,"city":45,"state":46,"zip":61,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Toronto Western Hospital","M5T 2S8",{"type":51,"coordinates":63},[53,54],{"lat":54,"lon":53},[66],{"name":67,"role":37,"phone":24,"phoneExt":24,"email":68},"Michael Reber, Ph.D","michael.reber@uhnresearch.ca",{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100493300","effectiveness-of-av-stimulation-in-immersive-vr-to-improve-visual-perception-and-driving-performance-100493300",false,"NCT05703360","Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance","Effectiveness of Audiovisual Stimulation in Immersive Virtual Reality to Improve Visual Perception and Driving Performance: a Pilot Study","Re:DriVR","Inclusion Criteria:\n\n* Male and female \\> 25 years old.\n* Visual field defects due to TBI or stroke\n* BCVA ≥ 20\u002F50.\n* Previously held a valid driving license and were active drivers.\n* Ability to follow the visual and auditory stimuli and training instructions.\n* Online auditory test positive (-5dBHL to 60dBHL range) at 125 Hz (for research purposes only)\n* Home Wi-Fi access.\n\nExclusion Criteria:\n\n* Both eyes with media opacity that impairs visual field testing.\n* Inability to perform during testing and training.\n* Cognitive\u002Fmotor condition incompatible with driving simulator and\u002For VR.\n* Recreational or medicinal consumption of psychoactive drugs.\n* 3 consecutive VRISE scores \\\u003C 25 at inclusion.\n* History of vertigo or dizziness.\n* Visual neglect.\n* Prior\u002Fcurrent vision rehabilitation interventions.\n* Photosensitive epilepsy.","ALL","25 Years",{"count":82,"type":83},30,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this clinical trial is to evaluate the effectiveness of an immersive virtual-reality (IVR) based stimulation program, in improving visual perception for people who have lost their driver's license due to perceptual or cognitive impairments.\n\nThe main questions it aims to answer are:\n\n1. Can the 6-week IVR stimulation program help improve driving performance?\n2. Will participants experience improvement in visual detection and perception after training?\n\nStudy Design Summary:\n\n* Participants will be randomized into a waitlist group or intervention-first group\n* The VR-based intervention will consist of training every 2 days for six weeks\n* Waitlist group will wait 6 weeks before starting intervention at study midpoint (week 7)\n* Intervention-first group will begin with intervention (week 1-6) and then stop intervention at study midpoint\n* Participants will complete tests related to driving performance, visual attention, and visual fields at the start of study, midpoint, and end of study\n\nResearchers will analyze data for changes from baseline in outcome measures.",[89,90,91,92,93,94,95,96,97],"Stroke","Visual Impairment","Low Vision","Virtual Reality","Visual Spatial Processing","Visual Field Defect","Visual Processing Speed","Cognitive Impairment","Driving Impaired","NOT_YET_RECRUITING","2024-12-16",{"date":101,"type":102},"2024-12-19","ACTUAL",{"date":104,"type":83},"2025-02-01",{"date":106,"type":83},"2025-12-01",{"name":5,"class":6},2]