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Recruiting NCT07496918

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

Phase II Interventional Cognitively Healthy People Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GENUS, Tactile GENUS.
Who it may be relevant to
Registry conditions: Cognitively Healthy People, Alzheimer Disease. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment

Overview

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:

1. Determine whether non-invasive 40Hz sensory stimulation (ie, light, sound, tactile) can change brain activity. 2. Evaluate whether devices delivering non-invasive 40Hz sensory stimulation are safe in cognitively normal adults. 3. Determine whether non-invasive 40Hz sensory stimulation can change brain connectivity, neuropsychological measures, blood biomarkers, and the microbiome.

Interventions

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

Primary outcome measures

  • Effects of GENUS on brain oscillations [Time frame: 1 year]
  • Effects of GENUS on brain oscillations [Time frame: 1 year]
  • Effects of GENUS on brain oscillations [Time frame: 1 year]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • MIT — Cambridge

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 PMID 36454969

Identifiers

NCT: NCT07496918 · 1712179268 · Aging Brain Initiative

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗