Cognitively Healthy PeoplePhase 2GENUSNCT07496918
Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)
A Phase 2 study testing GENUS and Tactile GENUS in people with Cognitively Healthy People and Alzheimer Disease, run by Massachusetts Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitively Healthy People, Alzheimer Disease
- What is being tested?
- GENUS and Tactile GENUS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 30 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MIT
Cambridge, Massachusetts, 02139
Ana Trisini Lipsanopoulos, BS, 617-258-7723, anat13@mit.edu
Ana Trisini Lipsanopoulos, BS
About this study
Official title: Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment
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.
Read the 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:
- 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.
- Conditions
- Cognitively Healthy People, Alzheimer Disease
- Being tested
- GENUS, Tactile GENUS
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENUSDevice
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 GENUSDevice
The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively normal adults | Experimental | Cognitively normal, healthy adults aged 18 - 100 Receives: Device: GENUS; Device: Tactile GENUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of GENUS on brain oscillations
Using Electroencephalogram (EEG), investigators will determine whether GENUS will affect brain oscillations, including those in the gamma band.
Measured: 1 year
Effects of GENUS on brain oscillations
Using Magnetoencephalography (MEG), investigators will determine whether GENUS will affect brain oscillations.
Measured: 1 year
Effects of GENUS on brain oscillations
Using magnetic resonance imaging (MRI), investigators will determine whether GENUS will affect brain oscillations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start20 Feb 2018
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitively Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Trisini Lipsanopoulos, BS, Study director, Massachusetts Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496918
- Sponsor's protocol ID
- 1712179268
- Other IDs
- Aging Brain Initiative
- Acronym
- GENUS
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36454969
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment
- ClinicalTrials.gov ID
- NCT07496918
- Acronym / sponsor ID
- GENUS / 1712179268
- Conditions
- Cognitively Healthy People, Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitively normal adults | Experimental | Device: GENUS, Device: Tactile GENUSCognitively normal, healthy adults aged 18 - 100 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENUSThe 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 | Cognitively normal adults |
| Tactile GENUSThe device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies. | Device | Cognitively normal adults |
Primary outcome
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.
Effects of GENUS on brain oscillations
Time frame: 1 year
Using Magnetoencephalography (MEG), investigators will determine whether GENUS will affect brain oscillations.
Effects of GENUS on brain oscillations
Time frame: 1 year
Using magnetic resonance imaging (MRI), investigators will determine whether GENUS will affect brain oscillations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 36454969Chan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Trisini Lipsanopoulos, BS study director
Massachusetts Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GENUS and Tactile GENUS in people with Cognitively Healthy People and Alzheimer Disease, run by Massachusetts Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gamma wave (617-258-7723, gamma.wave@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of GENUS on brain oscillations (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07496918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.