[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574687":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":52,"centralContacts":57,"locations":67,"responsibleParty":91,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":61,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":61,"enrollmentInfo":106,"targetDuration":61,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":118,"whyStopped":61,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Queen's University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Nonlinear dynamical neurofeedback (NLD)","EXPERIMENTAL","The NLD study intervention will consist of 10 sessions of NeurOptimal neurofeedback delivered twice a week over a 5-week period. The intervention will be delivered by a certified NeurOptimal trainer. The average session length is 45 minutes including setup. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed.",[13],"Other: Nonlinear dynamical neurofeedback (NLD)",{"label":15,"type":10,"description":16,"interventionNames":17},"Low energy neurofeedback system (LENS)","The LENS study intervention will consist of 5 sessions of LENS neurofeedback delivered by a certified LENS trainer once a week over a 5-week period. The average session length is 15 minutes including setup. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed.",[18],"Other: Low energy neurofeedback system (LENS)",{"label":20,"type":10,"description":21,"interventionNames":22},"Brain Music","The Brain Music study intervention will consist of a brain mapping data acquisition session to create the personalized music, followed by 5 weekly sessions to adjust the music that participants will listen to at home on a daily basis. Initial data acquisition and weekly sessions will take about 30 minutes. Additional time of 15-20 minutes will be required prior to sessions when the surveys are completed.",[23],"Other: Brain Music",{"label":25,"type":6,"description":26,"interventionNames":27},"Usual Care","The Usual Care control group will continue to be followed in the Memory clinic at intervals determined by their clinician. Participants will complete the pretest and post-test assessments and surveys at baseline and at the end of 5 weeks.",[28],"Other: Usual Care",[30,36,41,47],{"type":6,"name":9,"description":31,"armGroupLabels":32,"otherNames":33},"NeurOptimal nonlinear dynamical (NLD) neurofeedback brain training works as a detection and monitoring system of changes in cortical patterns within the brain, mirroring the brain activity that can be undermining optimal brain function, providing the brain with the information it needs to make its own adjustments which over time results in the brain functioning more efficiently and effectively. Two scalp sensors at C3 \\& C4 and two earclips at tops of ears (reference) and one on the earlobe (ground) are used to read EEG activity which is analyzed by the NeurOptimal software. As participants listen to music through earbuds, information is fed back to the individual by slight interruptions in the music. One session lasts 33.5 minutes.",[9],[34,35],"NeurOptimal neurofeedback","Brain training",{"type":6,"name":15,"description":37,"armGroupLabels":38,"otherNames":39},"Low energy neurofeedback system (LENS) therapy is an EEG-based direct neurofeedback system that stimulates the brain to reset itself and achieve optimal performance. Therapy consists of delivery of a tiny electromagnetic field carrying the feedback signal down the electrode wires for only one second at each of the chosen electrode sites during every session. Generally, between one and seven of the ordinary electrode sites are utilized during each session. Therapy is adapted to the participant's reactivity\u002Fsensitivity and the response of their nervous system.",[15],[40],"Direct neurofeedback",{"type":6,"name":20,"description":42,"armGroupLabels":43,"otherNames":44},"Chen Medimo Corp (CMC) Brain Music neurofeedback analyzes an individual's EEG brainwave patterns and translates them into orchestral music. Listening to this personalized brain music allows the individual to gain self-awareness and rewire and alter their own mental states. The Brain Music protocol requires regular in-person follow-ups for optimal results. Generally, the number of sessions varies based on individual needs and the progress made in response to the CMC Brain Music. A minimum of once a week in-person sessions is recommended for qEEG model updating to accurately track progress. Each session may last 30 minutes. Additionally, participants are advised to listen to their personalised music at least once a day, with a minimum of two listens per session. In general, participants may start to detect a change in their neurodevelopmental or cognitive function in 4-6 weeks.",[20],[45,46],"Chen Medimo Corp. (CMC)","CMC Brain Music",{"type":6,"name":25,"description":48,"armGroupLabels":49,"otherNames":50},"The Usual Care control group will be followed in the Memory clinic at intervals determined by their clinician. Usual Care for individuals with mild cognitive impairment (MCI) at the The Memory Clinic consists of inter-professional assessment, diagnosis and recommendations. There are currently no drugs approved to treat MCI. Therapy is aimed at managing treatable causes and contributors including medication side effects, thyroid problems, sleep apnea, vitabim B deficiency, depression, anxiety, and unrecognized or untreated difficulties with hearing or vision. Neurofeedback is not a component of the standard of care.",[25],[51],"Control group",[53],{"name":54,"affiliation":55,"role":56},"Marian Luctkar-Flude, PhD","Queen's University, School of Nursing","PRINCIPAL_INVESTIGATOR",[58,63],{"name":54,"role":59,"phone":60,"phoneExt":61,"email":62},"CONTACT","613-888-6335",null,"mfl1@queensu.ca",{"name":64,"role":59,"phone":65,"phoneExt":61,"email":66},"Sarah Moore-Vasram, PhD","613-483-3872","moorevas@providencecare.ca",[68],{"facility":69,"status":61,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Providence Care Hospital","Kingston","Ontario","K7L 4X3","Canada","CA",{"type":76,"coordinates":77},"Point",[78,79],-76.48098,44.22976,{"lat":79,"lon":78},[82,86,90],{"name":83,"role":59,"phone":84,"phoneExt":85,"email":66},"Sarah Moore-Vasram","613-544-4900","53540",{"name":87,"role":59,"phone":88,"phoneExt":61,"email":89},"Sarah Walker","613-484-3249","walker.s@queensu.ca",{"name":83,"role":59,"phone":61,"phoneExt":61,"email":61},{"type":56,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"Marian Luctkar-Flude, RN, PhD","Associate Professor",[95],{"name":96,"class":6},"Providence Health & Services","100574687","exploring-feasibility-acceptability-and-impact-of-using-neurofeedback-with-persons-with-mild-cognitive-impairment-100574687",false,"NCT06762522","Exploring Feasibility, Acceptability and Impact of Using Neurofeedback with Persons with Mild Cognitive Impairment","Exploring Feasibility and Acceptability of Using Neurofeedback Interventions to Manage Cognitive, Affective and Behavioural Symptoms in Persons with Mild Cognitive Impairment","Inclusion Criteria:\n\n* Adults with mild cognitive impairment (MCI) attending the Memory Clinic at Providence Care Hospital in Kingston, Ontario\n\nExclusion Criteria:\n\n* Adults with cognitive issues related to a psychiatric diagnosis or acute brain injury","ALL","55 Years",{"count":107,"type":108},20,"ESTIMATED","INTERVENTIONAL",[111],"NA","The goal of this pilot study is to determine the feasibility, acceptability and potential impact of using neurofeedback interventions to manage cognitive, emotional, and behavioural symptoms in individuals with mild cognitive impairment (MCI). The main question\\[s\\] it aims to answer are: (1) What is the feasibility, acceptability, and appropriateness of using the Nonlinear Dynamical Neurofeedback intervention for persons living with MCI? (2) What is the feasibility, acceptability, and appropriateness of using the Low Energy Neurofeedback System (LENS) intervention for persons living with MCI? (3) What is the feasibility, acceptability, and appropriateness of using the Brain Music neurofeedback intervention for persons living with MCI? (4) What is the potential impact of five weeks of a neurofeedback intervention on cognitive, affective, and behavioural symptoms experienced by persons living with MCI? Participants will be randomly assigned to either the Nonlinear Dynamical (NLD), Low Energy Neurofeedback System (LENS), or Brain Music neurofeedback intervention groups or a control group receiving usual care.",[114],"Mild Cognitive Impairment",[116,117],"Neurofeedback","Feasibility","NOT_YET_RECRUITING","2025-01-05",{"date":121,"type":122},"2025-01-07","ACTUAL",{"date":124,"type":108},"2025-01-27",{"date":126,"type":108},"2026-01-30",{"name":5,"class":6},1]