Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)
GENUS
Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment
2 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2018
CompletedFirst Submitted
Initial submission to the registry
January 9, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
March 27, 2026
March 1, 2026
8.9 years
January 9, 2025
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Effects of GENUS on brain oscillations
Using Electroencephalogram (EEG), investigators will determine whether GENUS will affect brain oscillations, including those in the gamma band.
1 year
Effects of GENUS on brain oscillations
Using Magnetoencephalography (MEG), investigators will determine whether GENUS will affect brain oscillations.
1 year
Effects of GENUS on brain oscillations
Using magnetic resonance imaging (MRI), investigators will determine whether GENUS will affect brain oscillations.
1 year
Other Outcomes (7)
Effects of GENUS on the microbiome
1 year
Effect of GENUS on blood biomarkers
1 year
Effect of GENUS on brain connectivity
1 year
- +4 more other outcomes
Study Arms (1)
Cognitively normal adults
EXPERIMENTALCognitively normal, healthy adults aged 18 - 100
Interventions
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.
The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MIT
Cambridge, Massachusetts, 02139, United States
Related Publications (1)
Chan D, Suk HJ, Jackson BL, Milman NP, Stark D, Klerman EB, Kitchener E, Fernandez Avalos VS, de Weck G, Banerjee A, Beach SD, Blanchard J, Stearns C, Boes AD, Uitermarkt B, Gander P, Howard M 3rd, Sternberg EJ, Nieto-Castanon A, Anteraper S, Whitfield-Gabrieli S, Brown EN, Boyden ES, Dickerson BC, Tsai LH. Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results of feasibility and pilot studies. PLoS One. 2022 Dec 1;17(12):e0278412. doi: 10.1371/journal.pone.0278412. eCollection 2022.
PMID: 36454969RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ana Trisini Lipsanopoulos, BS
Massachusetts Institute of Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2025
First Posted
March 27, 2026
Study Start
February 20, 2018
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
January 30, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03