40Hz light, sound, and touch stimulation to change brain activity in people with and without Alzheimer's disease.
Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment
This one-day visit will test whether non-invasive 40Hz light, sound, and touch stimulation can change brain activity, connectivity, and blood markers in cognitively normal adults and people with Alzheimer's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT07496918 on ClinicalTrials.gov |
What this trial studies
Participants receive non-invasive 40Hz sensory stimulation (light, sound, and tactile) using GENUS devices during a one-day visit at MIT while investigators record brain activity and safety measures. The team uses EEG and MEG to measure neural oscillations, MRI to examine structure and connectivity, neuropsychological testing for cognition, and blood and microbiome sampling in subsets of participants. The primary goals are to see if 40Hz stimulation alters gamma-band activity and related biomarkers and to confirm the devices are safe in cognitively normal adults. People with a history of seizures or MRI contraindications are excluded from participation.
Who should consider this trial
Good fit: Adults who are cognitively normal or have Alzheimer's disease, have adequate vision and hearing for sensory stimulation, can complete MRI/EEG and testing, and have no history of seizures or MRI contraindications are the ideal candidates.
Not a fit: People with a history of seizures, epilepsy, or MRI contraindications or those who cannot tolerate sensory stimulation are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could offer a noninvasive, potentially low-cost way to modify brain activity and slow cognitive decline.
How similar studies have performed: Preclinical work and early human studies have shown promising effects of 40Hz stimulation on pathology and brain activity, but larger clinical evidence of benefit is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cambridge, Massachusetts
- MIT — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: gamma wave
- Email: gamma.wave@mit.edu
- Phone: 617-258-7723
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.