{"id":52493,"date":"2025-08-20T17:39:34","date_gmt":"2025-08-20T21:39:34","guid":{"rendered":"https:\/\/www.vielight.com\/?p=52493"},"modified":"2025-10-21T11:43:03","modified_gmt":"2025-10-21T15:43:03","slug":"mild-cognitive-impairment-mci-clinical-trial-recruitment-university-of-toronto-unity-health-toronto-vielight-neuro-n60","status":"publish","type":"post","link":"https:\/\/www.vielight.com\/blog\/mild-cognitive-impairment-mci-clinical-trial-recruitment-university-of-toronto-unity-health-toronto-vielight-neuro-n60\/","title":{"rendered":"Mild Cognitive Impairment (MCI) Clinical Trial Recruitment | University of Toronto | Unity Health Toronto | Vielight Neuro (n=60)"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p data-start=\"72\" data-end=\"314\"><b><span data-ogsc=\"black\" data-olk-copy-source=\"MessageBody\">Do you\u2014or someone you love\u2014notice recent memory changes?<\/span><\/b><span data-ogsc=\"black\">\u00a0You may be eligible for a research study at St. Michael\u2019s Hospital in Toronto. This study investigates\u00a0<b data-ogsc=\"\">PBM therapy<\/b>, a non-invasive method that uses <b data-ogsc=\"\">near-infrared (NIR)<\/b>\u00a0light\u2014to see whether it can support brain health in people with memory concerns.<\/span><\/p>\n<p data-start=\"72\" data-end=\"314\">For more details about this MCI clinical trial: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06618807\" target=\"_blank\" rel=\"noopener\">https:\/\/clinicaltrials.gov\/study\/NCT06618807<\/a><\/p>\n<hr data-start=\"316\" data-end=\"319\" \/>\n<h2 data-start=\"321\" data-end=\"346\">Why this study matters<\/h2>\n<p data-start=\"348\" data-end=\"801\">MCI is a transitional state between normal aging and Alzheimer\u2019s dementia. On average, about <strong data-start=\"441\" data-end=\"448\">32%<\/strong> of people with MCI progress to dementia, <strong data-start=\"490\" data-end=\"497\">62%<\/strong> remain stable, and roughly <strong data-start=\"525\" data-end=\"531\">6%<\/strong> return to normal cognition at later visits. While some medications (e.g., <strong data-start=\"606\" data-end=\"657\">donepezil, galantamine, rivastigmine, memantine<\/strong>) can help with symptoms, there\u2019s still a need for <strong data-start=\"708\" data-end=\"724\">safe options<\/strong> that may support longer-term cognitive function with <strong data-start=\"778\" data-end=\"800\">fewer side effects<\/strong>.<\/p>\n<p data-start=\"803\" data-end=\"986\">This study investigates <strong data-start=\"827\" data-end=\"842\">PBM therapy<\/strong>\u2014a non-invasive method that uses gentle <strong data-start=\"882\" data-end=\"905\">near-infrared (NIR)<\/strong> light\u2014to see whether it can support brain health in people with memory concerns.<\/p>\n<hr data-start=\"988\" data-end=\"991\" \/>\n<h2 data-start=\"993\" data-end=\"1011\">About the study<\/h2>\n<ul data-start=\"1013\" data-end=\"1686\">\n<li data-start=\"1013\" data-end=\"1301\">\n<p data-start=\"1015\" data-end=\"1150\"><strong data-start=\"1015\" data-end=\"1033\">Device tested:<\/strong> <strong data-start=\"1034\" data-end=\"1064\">Neuro RX Gamma<\/strong>, a wearable headset with <strong data-start=\"1090\" data-end=\"1100\">5 LEDs<\/strong> plus an <strong data-start=\"1114\" data-end=\"1139\">intranasal applicator<\/strong> (1 LED).<\/p>\n<\/li>\n<li data-start=\"1302\" data-end=\"1466\">\n<p data-start=\"1304\" data-end=\"1466\"><strong data-start=\"1304\" data-end=\"1322\">How the device works:<\/strong> The Vielight Neuro delivers 810nm NIR light to targeted brain regions. It is <strong data-start=\"1393\" data-end=\"1408\">non-thermal<\/strong> (does not produce significant heat) and <strong data-start=\"1449\" data-end=\"1465\">non-invasive<\/strong>.<\/p>\n<\/li>\n<li data-start=\"1467\" data-end=\"1625\">\n<p data-start=\"1469\" data-end=\"1625\"><strong data-start=\"1469\" data-end=\"1480\">Design:<\/strong> <strong>60+ participants<\/strong> will use either an <strong data-start=\"1513\" data-end=\"1523\">active<\/strong> or <strong data-start=\"1527\" data-end=\"1535\">sham<\/strong> (placebo-like) Neuro RX Gamma device, allowing researchers to compare outcomes fairly.<\/p>\n<\/li>\n<li data-start=\"1626\" data-end=\"1661\">\n<p data-start=\"1628\" data-end=\"1661\"><strong data-start=\"1628\" data-end=\"1641\">Duration:<\/strong> <strong data-start=\"1642\" data-end=\"1654\">12 weeks<\/strong> total.<\/p>\n<\/li>\n<li data-start=\"1662\" data-end=\"1686\">\n<p data-start=\"1664\" data-end=\"1686\"><strong data-start=\"1664\" data-end=\"1677\">Location:<\/strong> Toronto.<\/p>\n<\/li>\n<\/ul>\n<blockquote data-start=\"1688\" data-end=\"1837\">\n<p data-start=\"1690\" data-end=\"1837\"><strong data-start=\"1690\" data-end=\"1704\">Important:<\/strong> PBM is being studied here to understand potential benefits; it is <strong data-start=\"1771\" data-end=\"1778\">not<\/strong> an approved treatment for MCI. Participation is voluntary.<\/p>\n<\/blockquote>\n<hr data-start=\"1839\" data-end=\"1842\" \/>\n<h2 data-start=\"1844\" data-end=\"1860\">Who can apply<\/h2>\n<p data-start=\"1862\" data-end=\"1891\">You may be a good fit if you:<\/p>\n<ul data-start=\"1893\" data-end=\"2067\">\n<li data-start=\"1893\" data-end=\"1927\">\n<p data-start=\"1895\" data-end=\"1927\">Are <strong data-start=\"1899\" data-end=\"1920\">50 years or older<\/strong>, and<\/p>\n<\/li>\n<li data-start=\"1928\" data-end=\"2067\">\n<p data-start=\"1930\" data-end=\"2067\">Have noticed <strong data-start=\"1943\" data-end=\"1961\">memory changes<\/strong> (e.g., forgetfulness, word-finding, misplacing items), <strong data-start=\"2017\" data-end=\"2047\">without a formal diagnosis<\/strong> of MCI or dementia.<\/p>\n<\/li>\n<li data-start=\"1928\" data-end=\"2067\"><span data-olk-copy-source=\"MessageBody\">You are able to undergo a b<strong>lood test and an MRI scan<\/strong> (Exceptions for undergoing MRI may be allowed)<\/span><\/li>\n<\/ul>\n<p data-start=\"2069\" data-end=\"2163\">If you\u2019re unsure, the study team can guide you through a brief screening to check eligibility.<\/p>\n<hr data-start=\"2165\" data-end=\"2168\" \/>\n<h2 data-start=\"2170\" data-end=\"2202\">What participation looks like<\/h2>\n<ul>\n<li class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\" data-olk-copy-source=\"MessageBody\">Screening &amp; consent:<\/span><\/b><span data-ogsc=\"black\">\u00a0<\/span>Undergo an initial assessment to determine eligibility for the study.<\/li>\n<li class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\">Baseline visit:<\/span><\/b><span data-ogsc=\"black\"><span data-ogsc=\"black\">\u00a0Assessments of memory and thinking, blood draw, and brain MRI (MRI exceptions allowed)<\/span><\/span>&nbsp;<\/li>\n<li class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\">At-home use:<\/span><\/b><span data-ogsc=\"black\"><span data-ogsc=\"black\">\u00a020 minutes daily, 6 days a week, for 8 weeks<\/span><\/span>&nbsp;<\/li>\n<li class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\">Check-ins:<\/span><\/b><span data-ogsc=\"black\"><span data-ogsc=\"black\">\u00a0Short follow-ups to track how you\u2019re doing.<\/span><\/span>&nbsp;<\/li>\n<li class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\">Post-<\/span><\/b><b><span data-ogsc=\"black\">Trial Evaluation<\/span><\/b><span data-ogsc=\"black\"><span data-ogsc=\"black\">: Repeat assessments to measure any changes over the 8 weeks.<\/span><\/span>&nbsp;<\/li>\n<li class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\">Follow-up visit:<\/span><\/b><span data-ogsc=\"black\">\u00a04 weeks after the Post-Trial Evaluation, repeat memory assessments and blood draw to measure lasting effects.<\/span><\/li>\n<\/ul>\n<p data-start=\"2615\" data-end=\"2750\">The team will teach you exactly how to place and use the device. LEDs are standard, semiconductor light sources\u2014no surgery, no needles.<\/p>\n<hr data-start=\"2752\" data-end=\"2755\" \/>\n<h2 data-start=\"2757\" data-end=\"2766\">Safety<\/h2>\n<p data-start=\"2768\" data-end=\"2946\">PBM at low levels is generally considered <strong data-start=\"2810\" data-end=\"2837\">safe and well-tolerated<\/strong> in research settings. As with any study, you\u2019ll be informed of potential risks and can withdraw at any time.<\/p>\n<hr data-start=\"2948\" data-end=\"2951\" \/>\n<h2 data-start=\"2953\" data-end=\"2987\">Ready to learn more or sign up?<\/h2>\n<p data-start=\"2989\" data-end=\"3106\"><strong data-start=\"2989\" data-end=\"2999\">Phone:<\/strong> 416-360-4000 <strong data-start=\"3013\" data-end=\"3027\">ext. 47838<\/strong><br data-start=\"3027\" data-end=\"3030\" \/><strong data-start=\"3030\" data-end=\"3040\">Email:<\/strong> <a class=\"decorated-link cursor-pointer\" rel=\"noopener\" data-start=\"3041\" data-end=\"3106\">memoryclinic@unityhealth.to<\/a><\/p>\n<p data-start=\"3108\" data-end=\"3149\">When you reach out, you can simply say:<\/p>\n<blockquote data-start=\"3150\" data-end=\"3227\">\n<p data-start=\"3152\" data-end=\"3227\">\u201cI\u2019m interested in the photobiomodulation memory study for people over 50.\u201d<\/p>\n<\/blockquote>\n<hr data-start=\"3229\" data-end=\"3232\" \/>\n<h2 data-start=\"3234\" data-end=\"3246\">Quick FAQ<\/h2>\n<p data-start=\"3248\" data-end=\"3370\"><strong data-start=\"3248\" data-end=\"3272\">Is this a treatment?<\/strong><br data-start=\"3272\" data-end=\"3275\" \/>This is a <strong data-start=\"3285\" data-end=\"3312\">clinical research study<\/strong> to evaluate PBM; it is not established treatment for MCI.<\/p>\n<p data-start=\"3372\" data-end=\"3544\"><strong data-start=\"3372\" data-end=\"3404\">Do I need a diagnosis first?<\/strong><br data-start=\"3404\" data-end=\"3407\" \/><strong data-start=\"3407\" data-end=\"3414\">No.<\/strong> If you\u2019re over 50 and noticing memory changes\u2014but don\u2019t have a formal diagnosis\u2014you\u2019re welcome to contact the team for screening.<\/p>\n<p data-start=\"3546\" data-end=\"3733\"><strong data-start=\"3546\" data-end=\"3590\">Will I definitely get the active device?<\/strong><br data-start=\"3590\" data-end=\"3593\" \/>Not necessarily. To ensure fair results, some participants use a <strong data-start=\"3658\" data-end=\"3666\">sham<\/strong> device. You\u2019ll learn which you had after the study, if applicable.<\/p>\n<p data-start=\"3735\" data-end=\"3889\"><strong data-start=\"3735\" data-end=\"3773\">Can I keep my current medications?<\/strong><br data-start=\"3773\" data-end=\"3776\" \/>Please tell the study team about any medications. They\u2019ll advise you on eligibility and any required adjustments.<\/p>\n<hr \/>\n<h2 data-start=\"3234\" data-end=\"3246\">About the Device<\/h2>\n<p class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\" data-olk-copy-source=\"MessageBody\">The Neuro RX Gamma<\/span><\/b><span data-ogsc=\"black\">, a wearable headset with\u00a0<b data-ogsc=\"\">5 LEDs<\/b>\u00a0plus an\u00a0<b data-ogsc=\"\">intranasal applicator<\/b>\u00a0(1 LED).<\/span><\/p>\n<p class=\"x_MsoNormal\" data-ogsb=\"white\"><span data-ogsc=\"black\">It<\/span><span data-ogsc=\"black\">\u00a0delivers 810nm NIR light to targeted brain regions. It is\u00a0<b data-ogsc=\"\">non-thermal<\/b>\u00a0(does not produce significant heat) and\u00a0<b data-ogsc=\"\">non-invasive<\/b>.<\/span><\/p>\n<p class=\"x_MsoNormal\" data-ogsb=\"white\"><b><span data-ogsc=\"black\">Safety<\/span><\/b><span data-ogsc=\"black\">: PBM at low levels is generally considered\u00a0<b data-ogsc=\"\">safe and well-tolerated<\/b>\u00a0in research settings. As with any study, you\u2019ll be informed of potential risks and can withdraw at any time.<\/span><\/p>\n<p class=\"x_MsoNormal\" data-ogsb=\"rgb(246, 246, 246)\"><b><i><span data-ogsc=\"black\">Important:<\/span><\/i><\/b><i><span data-ogsc=\"black\">\u00a0PBM is being studied here to understand potential benefits; it is\u00a0<b data-ogsc=\"\">not<\/b>\u00a0an approved treatment for MCI. Participation is voluntary.<\/span><\/i><\/p>\n<hr data-start=\"3891\" data-end=\"3894\" \/>\n<h2 data-start=\"3896\" data-end=\"3935\">Share with a friend or family member<\/h2>\n<p data-start=\"3937\" data-end=\"4152\">If you know someone 50+ who\u2019s been <strong data-start=\"3972\" data-end=\"4056\">forgetting appointments, repeating questions, or feeling more \u201cfoggy\u201d than usual<\/strong>, please share this post. Early participation in research can help advance options for everyone.<\/p>\n<hr data-start=\"4154\" data-end=\"4157\" \/>\n<p data-start=\"4159\" data-end=\"4345\" data-is-last-node=\"\" data-is-only-node=\"\"><em data-start=\"4159\" data-end=\"4345\" data-is-last-node=\"\">This post is for recruitment and general information only. It does not replace medical advice. Speak with your healthcare provider about any concerns regarding your memory or thinking.<\/em><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":52494,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"bwfblock_default_font":"","inline_featured_image":false,"mc4wp_mailchimp_campaign":[],"footnotes":""},"categories":[3012,3114],"tags":[],"class_list":["post-52493","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-alzheimers","category-mild-cognitive-impairment-mci"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts\/52493","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/comments?post=52493"}],"version-history":[{"count":0,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/posts\/52493\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/media\/52494"}],"wp:attachment":[{"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/media?parent=52493"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/categories?post=52493"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vielight.com\/wp-json\/wp\/v2\/tags?post=52493"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}