Health TrialsbyHealthPanel

Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)

ConditionsCognitively Healthy PeopleAlzheimer Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorMassachusetts Institute of Technology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • Tactile GENUS

    Device

    The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Cognitively normal adultsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Effects of GENUS on brain oscillations

Using Electroencephalogram (EEG), investigators will determine whether GENUS will affect brain oscillations, including those in the gamma band.

Time frame
1 year
2

Effects of GENUS on brain oscillations

Using Magnetoencephalography (MEG), investigators will determine whether GENUS will affect brain oscillations.

Time frame
1 year
3

Effects of GENUS on brain oscillations

Using magnetic resonance imaging (MRI), investigators will determine whether GENUS will affect brain oscillations.

Time frame
1 year

Secondary outcomes

Other outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

Effect of GENUS on brain connectivity

Using Electroencephalogram (EEG), we will evaluate whether GENUS will affect brain connectivity, including those involved in gamma oscillations.

Time frame
1 year
4

Effect of GENUS on brain connectivity

Using Magnetoencephalography (MEG), we will evaluate whether GENUS will affect brain connectivity.

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Institute of Technology

Lead sponsor

Source ClinicalTrials.gov
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