[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568146":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":19,"enrollmentInfo":74,"targetDuration":19,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"HealthTech Connex Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NeuroCatch® Platform 2","OTHER","NeuroCatch® Platform 2 Software enables EEG data collection by recording the data during an audio stimulus presentation (i.e., the NeuroCatch® Scan). The Software plays a 6-min proprietary audio sequence stimulus. The NeuroCatch® software generates unique, randomized audio sequences specifically designed to elicit specific brain responses. Once a NeuroCatch® Scan is complete, the software automatically processes the raw EEG data to generate 6 ERP results and saves the results, the data, and details about the scan to the secure NeuroCatch® server in the cloud.\n\nWhile EEG is only collected during the scan, the participant is exposed to the device from the time the cap is placed on the head until it is taken off.\n\nDuring the scan, the participant will listen to an auditory stimulus sequence consisting of tones and words. This has been designed and limited to safe audio levels.",[13],"Device: NeuroCatch® Platform 2",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The NeuroCatch® Platform 2, a medical device system developed by NeuroCatch Inc., consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP; brain response to a stimulus) information. The device is approved as a medical device by Health Canada.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Jan Venter, MD","Centre for Neurology Studies","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Sonia Brodie","CONTACT","604-308-5900","cnsneurostudies@gmail.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":30},"Monica Vo","778-735-1986",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Centre for Neurology Studies, 13761 96 Ave, Unit 1004","RECRUITING","Surrey","British Columbia","V3V 0E8","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-122.82509,49.10635,{"lat":47,"lon":46},[50,54,57],{"name":51,"role":28,"phone":52,"phoneExt":19,"email":53},"Rianne Buijs","7787351917","riannebuijs@healthtechconnex.com",{"name":55,"role":28,"phone":56,"phoneExt":19,"email":19},"Julia Joyes","778-735-1945",{"name":22,"role":28,"phone":19,"phoneExt":19,"email":19},{"type":59,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[61],{"name":62,"class":6},"NeuroCatch Inc.","100568146","neurocatch-reference-interval-database-100568146",false,"NCT06677424","NeuroCatch Reference Interval Database","Empirical Distributions of ERP Components Elicited by the NeuroCatch® Platform 2: Development of a Reference Interval Database","RR","INCLUSION CRITERIA\n\n1. Any sex, at least 6 years of age or older\n2. Able to understand the informed consent\u002Fassent form (in English), study procedures and willing to participate in study; participants under 19 must also have a parent\u002Fguardian who is able to understand and provide informed consent on their behalf.\n3. Able to remain seated and focused for 7 minutes\n4. In good health with no history of clinically relevant neurological illness or injury\n\nEXCLUSION CRITERIA\n\n1. Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to hearing (e.g., punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.\n2. Implanted pacemaker or other electrical stimulator(s)\n3. Metal or plastic implants in the skull, excluding dental\u002Ffacial implants.\n4. Not native-level in English\n5. Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months\n6. History of clinically relevant neurological disorders or injury (e.g., epilepsy, Parkinson's disease, traumatic brain injury, etc.)\n7. History of chronic pain or chronic headache disorders (e.g. migraine, tension headaches, fibromyalgia, etc.)\n8. Currently diagnosed with any sleeping disorders (e.g. sleep apnea, hypersomnia, insomnia, parasomnia, etc.)\n9. Diagnosed with any memory disorders.\n10. History of clinically relevant major psychiatric disorders (e.g., schizophrenia, bipolar disorder, etc.)\n11. History of alcohol or substance misuse that, in the opinion of the Investigator, may impact brain function\n12. Use of medications that affect brain function (e.g., antiepileptic drugs, antipsychotics, stimulants, etc.)\n13. Serious medical conditions affecting brain functions (e.g., stroke, brain tumor, neurodegenerative diseases, etc.)\n14. Undergoing chemotherapy or any form of intensive long-term therapy that, in the opinion of the Investigator, may impact brain function.\n15. Unhealthy scalp (e.g., apparent open wounds and\u002For bruised or weakened skin)\n16. Allergy to EEG gel",true,"ALL","6 Years",{"count":75,"type":76},810,"ESTIMATED","INTERVENTIONAL",[79],"NA","The purpose of this study is to understand how the brain responds to sounds and words, and how this response varies between individuals. The purpose if this study is to develop data set comparing the results from one individual with those from other members (a reference interval database of NeuroCatch® Platform 2) and to quantify the expected distribution across sex and age. NeuroCatch® Platform 2, is a medical device approved by Health Canada. The plan is to enroll 810 participants, the study includes screening for eligibility and one brain scan. The study is conducted at the Centre for Neurology Studies in Surrey, BC or at its satellite sites ( if required).",[82,83],"Healthy Controls","Brain Function",[85],"Brain Scan, NeuroCatch®","2024-11-05",{"date":88,"type":89},"2024-11-06","ACTUAL",{"date":91,"type":89},"2024-08-05",{"date":93,"type":76},"2026-08",{"name":5,"class":6},1]