[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631149":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":17,"armGroups":44,"interventions":52,"overallOfficials":62,"centralContacts":66,"locations":74,"responsibleParty":93,"collaborators":17,"id":95,"slug":17,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":55,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":17,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":17,"overallStatus":77,"whyStopped":17,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Massachusetts Institute of Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":18},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Effects of GENUS on brain oscillations","Using Electroencephalogram (EEG), investigators will determine whether GENUS will affect brain oscillations, including those in the gamma band.","1 year",{"measure":10,"description":14,"timeFrame":12},"Using Magnetoencephalography (MEG), investigators will determine whether GENUS will affect brain oscillations.",{"measure":10,"description":16,"timeFrame":12},"Using magnetic resonance imaging (MRI), investigators will determine whether GENUS will affect brain oscillations.",null,[19,22,25,28,30,32,35],{"measure":20,"description":21,"timeFrame":12},"Effects of GENUS on the microbiome","The microbiome will be evaluated after a single session of GENUS stimulation Subjects will produce a fecal sample and hand it off to study staff for storage and sample processing using the QIAamp PowerFecal Pro DNA Kit (Qiagen). Data will then be analyzed using the Divisive Amplicon Denoising Algorithm 2 (DADA2) pipeline, which will provide gut microbial composition in the different experimental groups. Pipeline outputs involve principal component analyses, and a custom in-house script will be used to make statistical comparisons.",{"measure":23,"description":24,"timeFrame":12},"Effect of GENUS on blood biomarkers","After 1 hour of GENUS in a subset of participants, we will evaluate whether GENUS will affect blood based biomarkers.",{"measure":26,"description":27,"timeFrame":12},"Effect of GENUS on brain connectivity","Using Electroencephalogram (EEG), we will evaluate whether GENUS will affect brain connectivity, including those involved in gamma oscillations.",{"measure":26,"description":29,"timeFrame":12},"Using Magnetoencephalography (MEG), we will evaluate whether GENUS will affect brain connectivity.",{"measure":26,"description":31,"timeFrame":12},"Using magnetic resonance imaging (MRI), we will evaluate whether GENUS will affect brain connectivity.",{"measure":33,"description":34,"timeFrame":12},"Effects of GENUS on neuropsychiatric measures","After 1 hour of GENUS, a subset of participants will undergo neuropsychiatric evaluation with a preset battery of tests to evaluate for changes in cognition.",{"measure":33,"description":36,"timeFrame":12},"After 1 hour of GENUS, a subset of participants will undergo neuropsychiatric evaluation with a preset battery of tests to evaluate for changes in mood.",{"allocation":38,"interventionModel":39,"interventionModelDescription":17,"primaryPurpose":40,"observationalModel":17,"timePerspective":17,"maskingInfo":41},"NA","SEQUENTIAL","TREATMENT",{"masking":42,"maskingDescription":17,"whoMasked":17},"NONE","Information processing in the brain is thought to occur through synchronized neuronal activity in the form of network oscillations. Activity in the 30-100 Hz range is considered gamma-band oscillation and has been reported to be critical for attention, memory formation, and recall. Disruptions of gamma oscillations, particularly in the 30 - 50 Hz range, are reported as a potential early hallmark of Alzheimer's disease.\n\n40Hz gamma frequency stimulation was previously shown to reduce Alzheimer's disease pathology and improve cognitive outcomes. This study aims to:\n\n1. Determine whether non-invasive 40Hz sensory stimulation (ie, light, sound, tactile) can change brain activity.\n2. Evaluate whether devices delivering non-invasive 40Hz sensory stimulation are safe in cognitively normal adults.\n3. Determine whether non-invasive 40Hz sensory stimulation can change brain connectivity, neuropsychological measures, blood biomarkers, and the microbiome.",[45],{"label":46,"type":47,"description":48,"interventionNames":49},"Cognitively normal adults","EXPERIMENTAL","Cognitively normal, healthy adults aged 18 - 100",[50,51],"Device: GENUS","Device: Tactile GENUS",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":17},"DEVICE","GENUS","The device is a light and sound device that delivers light stimulation using light-emitting diodes (LED) and sound stimulation through a speaker, with a centrally-mounted tablet or phone that plays videos for entertainment. The device will be positioned on an easel such that the tablet is eye level with the participant while they are sitting 5 feet away or held in their hands. The active device delivers light and sound at 40Hz rate.",[46],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":17},"Tactile GENUS","The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.",[46],[63],{"name":64,"affiliation":5,"role":65},"Ana Trisini Lipsanopoulos, BS","STUDY_DIRECTOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":17,"email":71},"gamma wave","CONTACT","617-258-7723","gamma.wave@mit.edu",{"name":64,"role":69,"phone":70,"phoneExt":17,"email":73},"anat13@mit.edu",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"MIT","RECRUITING","Cambridge","Massachusetts","02139","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-71.10561,42.3751,{"lat":87,"lon":86},[90,91],{"name":64,"role":69,"phone":70,"phoneExt":17,"email":73},{"name":64,"role":92,"phone":17,"phoneExt":17,"email":17},"SUB_INVESTIGATOR",{"type":94,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100631149",false,"NCT07496918","Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)","Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment","Inclusion Criteria:\n\n* Have adequate visual and auditory acuity for visual and auditory stimulation to allow for neuropsychological testing.\n* Be able to comply with neuropsychological testing and other study procedures in opinion of site PI.\n\nExclusion Criteria: Participants will be screened for the following exclusion criteria including if they\n\n* History of seizure or medical diagnosis of epilepsy.\n* Have MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.\n* Under the discretion of the site investigator, the site investigator feels the subject cannot complete sufficient key study procedures. Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director.",true,"ALL","18 Years","100 Years",{"count":106,"type":107},150,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","Despite the huge healthcare and economic impact of AD, there is still no disease modifying therapeutics available. In fact, the available therapeutics show low efficacy at best in the treatment of cognitive impairment in dementia. Development of a non-invasive medical device that is effective in slowing cognitive impairment is not only revolutionary but also possibly cost- effective. In this study, participants will come to MIT for a 1-day visit and the investigators will evaluate the effects of GENUS in cognitively normal, healthy adults. Investigators will use Electroencephalogram (EEG), Magnetoencephalography (MEG), magnetic resonance imaging (MRI), neuropsychological testing, and blood sampling in subsets of participants to evaluate for biological effects and safety of GENUS stimulation.",[113,114],"Cognitively Healthy People","Alzheimer Disease","2026-03-24",{"date":117,"type":118},"2026-03-27","ACTUAL",{"date":120,"type":118},"2018-02-20",{"date":122,"type":107},"2027-01-30",{"name":5,"class":6},1]