MIT
Cambridge, Massachusetts, 02139, United States
Location status: Recruiting
Location contact
Ana Trisini Lipsanopoulos, BS
CONTACT
Ana Trisini Lipsanopoulos, BS
SUB_INVESTIGATOR
NCT Number: NCT07496918
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Phase 2
Cambridge, Massachusetts, 02139, United States
Location status: Recruiting
Ana Trisini Lipsanopoulos, BS
CONTACT
Ana Trisini Lipsanopoulos, BS
SUB_INVESTIGATOR
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be screened for the following exclusion criteria including if they
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.
Time frame: 1 year
Using Electroencephalogram (EEG), investigators will determine whether GENUS will affect brain oscillations, including those in the gamma band.
Time frame: 1 year
Using Magnetoencephalography (MEG), investigators will determine whether GENUS will affect brain oscillations.
Time frame: 1 year
Using magnetic resonance imaging (MRI), investigators will determine whether GENUS will affect brain oscillations.
Time frame: 1 year
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.
Time frame: 1 year
After 1 hour of GENUS in a subset of participants, we will evaluate whether GENUS will affect blood based biomarkers.
Time frame: 1 year
Using Electroencephalogram (EEG), we will evaluate whether GENUS will affect brain connectivity, including those involved in gamma oscillations.
Time frame: 1 year
Using Magnetoencephalography (MEG), we will evaluate whether GENUS will affect brain connectivity.
Time frame: 1 year
Using magnetic resonance imaging (MRI), we will evaluate whether GENUS will affect brain connectivity.
Time frame: 1 year
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.
Time frame: 1 year
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.
Contact information is provided by the study sponsor or research team.
Ana Trisini Lipsanopoulos, BS
CONTACT
gamma wave
CONTACT
Massachusetts Institute of Technology
Other
Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment
Acronym: GENUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06937229
Aberrant Motor Behavior in Dementia, Agitation
Chandler, Arizona, United States
View Trial DetailsNCT06862960
Alzheimer Disease, Brain Diseases
Fuzhou, Fujian, China
View Trial DetailsNCT06072963
Alzheimer Disease, Brain Diseases
Ramat Gan, Israel
View Trial DetailsNCT07721701
Alzheimer Disease, Arterial Occlusive Diseases
Aschaffenburg, Germany
View Trial Details