Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07496918

Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MIT

Cambridge, Massachusetts, 02139, United States

Location status: Recruiting

Location contact

Ana Trisini Lipsanopoulos, BS

CONTACT

[email protected]

617-258-7723

Ana Trisini Lipsanopoulos, BS

SUB_INVESTIGATOR

About this study

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:

  • Determine whether non-invasive 40Hz sensory stimulation (ie, light, sound, tactile) can change brain activity.
  • Evaluate whether devices delivering non-invasive 40Hz sensory stimulation are safe in cognitively normal adults.
  • Determine whether non-invasive 40Hz sensory stimulation can change brain connectivity, neuropsychological measures, blood biomarkers, and the microbiome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GENUS

Device

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.

Tactile GENUS

Device

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

Primary outcomes

  1. Effects of GENUS on brain oscillations

    Time frame: 1 year

    Using Electroencephalogram (EEG), investigators will determine whether GENUS will affect brain oscillations, including those in the gamma band.

  2. Effects of GENUS on brain oscillations

    Time frame: 1 year

    Using Magnetoencephalography (MEG), investigators will determine whether GENUS will affect brain oscillations.

  3. Effects of GENUS on brain oscillations

    Time frame: 1 year

    Using magnetic resonance imaging (MRI), investigators will determine whether GENUS will affect brain oscillations.

Other outcomes

  1. Effects of GENUS on the microbiome

    Time frame: 1 year

    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.

  2. Effect of GENUS on blood biomarkers

    Time frame: 1 year

    After 1 hour of GENUS in a subset of participants, we will evaluate whether GENUS will affect blood based biomarkers.

  3. Effect of GENUS on brain connectivity

    Time frame: 1 year

    Using Electroencephalogram (EEG), we will evaluate whether GENUS will affect brain connectivity, including those involved in gamma oscillations.

  4. Effect of GENUS on brain connectivity

    Time frame: 1 year

    Using Magnetoencephalography (MEG), we will evaluate whether GENUS will affect brain connectivity.

  5. Effect of GENUS on brain connectivity

    Time frame: 1 year

    Using magnetic resonance imaging (MRI), we will evaluate whether GENUS will affect brain connectivity.

  6. Effects of GENUS on neuropsychiatric measures

    Time frame: 1 year

    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.

  7. Effects of GENUS on neuropsychiatric measures

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Trisini Lipsanopoulos, BS

CONTACT

[email protected]

617-258-7723

gamma wave

CONTACT

[email protected]

617-258-7723

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Registry information

Official study title

Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment

Acronym: GENUS

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.