Alzheimer Disease, Cognitively Healthy People
Conditions
Brief summary
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.
Detailed description
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. 40Hz gamma frequency stimulation was previously shown to reduce Alzheimer's disease pathology and improve cognitive outcomes. This study aims to: 1. Determine whether non-invasive 40Hz sensory stimulation (ie, light, sound, tactile) can change brain activity. 2. Evaluate whether devices delivering non-invasive 40Hz sensory stimulation are safe in cognitively normal adults. 3. Determine whether non-invasive 40Hz sensory stimulation can change brain connectivity, neuropsychological measures, blood biomarkers, and the microbiome.
Interventions
DEVICEGENUS
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.
DEVICETactile GENUS
The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.
Sponsors
Massachusetts Institute of Technology
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Have adequate visual and auditory acuity for visual and auditory stimulation to allow for neuropsychological testing. * Be able to comply with neuropsychological testing and other study procedures in opinion of site PI.
Exclusion criteria
Participants will be screened for the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of GENUS on brain oscillations | 1 year | Using Electroencephalogram (EEG), investigators will determine whether GENUS will affect brain oscillations, including those in the gamma band. |
Countries
United States
Contacts
CONTACTgamma wave
CONTACTAna Trisini Lipsanopoulos, BS
STUDY_DIRECTORAna Trisini Lipsanopoulos, BS
Massachusetts Institute of Technology
Outcome results
None listed