Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)
Part of paid clinical trials in Cambridge, Massachusetts.
- Sponsor
- Massachusetts Institute of Technology
- Study ID
- NCT07496918
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Cognitively Healthy People
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Accepted
Interventions
- GENUS — DEVICEThe 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.
- Tactile GENUS — DEVICEThe device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.
Study Details
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.
Key Dates
- Start date
- Feb 20, 2018
- Status verified
- Mar 2026
- Primary completion
- Jan 30, 2027
- Completion
- Jan 30, 2027
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cognitively normal adultsCognitively normal, healthy adults aged 18 - 100
Primary Outcome Measure
Effects of GENUS on brain oscillations [ Time Frame: 1 year ]
Central Contacts
- gamma wave617-258-7723
- Ana Trisini Lipsanopoulos, BS617-258-7723
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MIT | Cambridge | Massachusetts | 02139 | Ana Trisini Lipsanopoulos, BS (SUB_INVESTIGATOR) |
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