Recruiting
Phase 2

GENUS

Sponsor:

Massachusetts Institute of Technology

Code:

NCT07496918

Conditions

Cognitively Healthy People

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

GENUS

Tactile GENUS

Study Details

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.

Conditions

Cognitively Healthy People

Alzheimer Disease

Study ID

NCT07496918

Start date

Feb 20, 2018

Status verified date

Mar, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitively normal adults

Cognitively normal, healthy adults aged 18 - 100

Interventions

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.

Tactile GENUS

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

Primary outcome measure

  • Effects of GENUS on brain oscillations [ Time Frame: 1 year ]
  • Effects of GENUS on brain oscillations [ Time Frame: 1 year ]
  • Effects of GENUS on brain oscillations [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

gamma wave

617-258-7723gamma.wave@mit.edu

Ana Trisini Lipsanopoulos, BS

617-258-7723anat13@mit.edu

Locations

MIT

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Ana Trisini Lipsanopoulos, BS

617-258-7723anat13@mit.edu

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2026-03-27.