Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Aging Brain Initiative | Other Identifier | MIT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitively normal adults | Experimental | Cognitively normal, healthy adults aged 18 - 100 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Effects of GENUS on the microbiome | 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. |
Inclusion Criteria:
Exclusion Criteria: Participants will be screened for the following exclusion criteria including if they
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gamma wave | Contact | 617-258-7723 | gamma.wave@mit.edu | |
| Ana Trisini Lipsanopoulos, BS | Contact | 617-258-7723 | anat13@mit.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ana Trisini Lipsanopoulos, BS | Massachusetts Institute of Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MIT | Recruiting | Cambridge | Massachusetts | 02139 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36454969 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tactile GENUS | Device | The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies. |
|
| 1 year |
| Effect of GENUS on blood biomarkers | After 1 hour of GENUS in a subset of participants, we will evaluate whether GENUS will affect blood based biomarkers. | 1 year |
| Effect of GENUS on brain connectivity | Using Electroencephalogram (EEG), we will evaluate whether GENUS will affect brain connectivity, including those involved in gamma oscillations. | 1 year |
| Effect of GENUS on brain connectivity | Using Magnetoencephalography (MEG), we will evaluate whether GENUS will affect brain connectivity. | 1 year |
| Effect of GENUS on brain connectivity | Using magnetic resonance imaging (MRI), we will evaluate whether GENUS will affect brain connectivity. | 1 year |
| Effects of GENUS on neuropsychiatric measures | 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. | 1 year |
| Effects of GENUS on neuropsychiatric measures | 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. | 1 year |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |