RECRUITINGPhase 2INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: Participants will be screened for the following exclusion criteria including if they - History of seizure or medical diagnosis of epilepsy. - 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. - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 exclusion criteria including if they * History of seizure or medical diagnosis of epilepsy. * 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. * 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.

Treatments Being Tested

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.

DEVICE

Tactile GENUS

The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.

Locations (1)

MIT

Cambridge, Massachusetts, United States