[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609063":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":39,"responsibleParty":64,"collaborators":27,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":27,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":42,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Oklahoma","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active near-infrared light therapy","ACTIVE_COMPARATOR","Participants in this arm will receive active transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will be administered.",[13],"Device: transcranial photobiomodulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham near-infrared light therapy","SHAM_COMPARATOR","Participants in this arm will receive sham transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will not be administered.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","transcranial photobiomodulation","The Vielight Neuro Gamma TPBM devices (©Vielight Inc.) will be used to transmit pulsed near-infrared (NIR) energy through the cranium. Device emits NIR photons at 810 m wavelength generating \\~100 mW\u002Fcm2 pulsed NIR power modulated at 40 Hz frequency. The six NIR light sources are positioned along the midline over the frontal, pariatel and occipital cortices, bilaterally over the temporal cortex, and intranasally. Due to its portable design, Vielight Neuro TBPM instruments can be used in the laboratory, bedside, or at the participant's home.\n\nActive \u002F sham photobiomodulation sessions last for 20 minutes and will be administered at a laboratory-, home-, or office-based setting depending on the preference of the participant. TPBM will be performed three or four times a week for four weeks, maximum once every other day. Participants will complete a questionnaire of adverse events after each photobiomodulation session.",[9,15],[26],"near-infrared light therapy",null,[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Peter Mukli, MD, PhD","CONTACT","+1 (405) 271-8001","37745","peter-mukli@ou.edu",{"name":36,"role":31,"phone":37,"phoneExt":27,"email":38},"Norbert S Dosa, MD","+1 (405) 271-8130","norbert-dosa@ou.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Oklahoma Health Campus","RECRUITING","Oklahoma City","Oklahoma","73104","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-97.51643,35.46756,{"lat":52,"lon":51},[55,58,61],{"name":56,"role":31,"phone":57,"phoneExt":33,"email":34},"Peter Mukli Mukli, MD PhD","405-271-8001",{"name":59,"role":31,"phone":60,"phoneExt":27,"email":27},"OUHSC Director, Office of H. R. P. P.","405-271-2045",{"name":62,"role":63,"phone":27,"phoneExt":27,"email":27},"Peter Mukli, MD PhD","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100609063","the-effect-of-near-infrared-light-therapy-on-brain-function-and-cognition-in-young-and-older-adults-100609063",false,"NCT07209683","The Effect of Near-infrared Light Therapy on Brain Function and Cognition in Young and Older Adults","Age-specific Neurovascular Effects of Transcranial Photobiomodulation","Inclusion Criteria:\n\n* Age: 21-85 years of age\n* Adequate hearing and visual acuity to participate in the examinations\n* Ability to read and write in English\n* Competence to provide informed consent\n\nExclusion Criteria:\n\n* Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer\n* Cerebrovascular accident other than TIA within 60 days prior to Visit 0\n* Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse\n* Participant currently uses commercial brain stimulation \u002F neuromodulation device or an experimental device as part of a research study, e.g. tDCS, tACS, TBS, DBS, TMS, TPBM, etc.\n* Participant currently takes dietary supplements with an expected cerebrovascular benefit, such as NAD- or NR-supplement, L-citrulline, urolithin\n* Unstable medical condition, including uncontrolled diabetes, chronic heart issues, heart failure, chronic obstructive pulmonary disease, Stage 2 hypertension uncontrolled by medication (\\>160\u002F100 mmHg)\n* Any other medical condition or medication which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol.\n* Pregnancy or trying to become pregnant in the next 1 months (self-reported), breastfeeding",true,"ALL","21 Years","85 Years",{"count":78,"type":79},30,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this pilot clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in older adults.\n\nThe main questions it aims to answer are:\n\n* Does tPBM enhance neurovascular coupling responses during memory and finger tapping tasks?\n* Are these improvements linked to better cognitive performance and lower levels of brain inflammation and oxidative stress?\n\nResearchers will compare an active tPBM treatment arm to a sham treatment arm to see if tPBM leads to measurable improvements in brain activity and cognitive function compared to no active stimulation.\n\nParticipants will:\n\n* Receive either active tPBM or sham stimulation sessions for 4 weeks, every other day using a portable intervention device.\n* Complete questionnaires and an iPAD-based cognitive testing protocol\n* Complete memory and motor tasks while their brain activity is measured using non-invasive techniques: simultaneous functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), transcranial doppler (TCD) flowmetry.\n* Retinal vessel reactivity will be measured during flickering light stimulus using a special camera (dynamic vessel analysis, DVA).\n* Provide blood samples to test for biomarkers of inflammation, oxidative stress and brain cell damage.",[85,86,87,88,89],"Cognition","Neurovascular Coupling Mechanism and Cognitive Function","Neurovascular Control","Brain Aging","Brain Activity",[22,91,92,93,94,95,96,97,98],"neurovascular coupling","aging","cognitive function","near-infrared spectroscopy","electroencephalography","dynamic vessel analysis","home-based intervention","randomized double-blinded clinical trial","2026-02-04",{"date":101,"type":102},"2026-02-06","ACTUAL",{"date":104,"type":102},"2025-10-01",{"date":106,"type":79},"2026-12-31",{"name":5,"class":6},1]