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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Massachusetts Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitively Healthy People
• Alzheimer Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-20
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study