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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how GENUS devices, including light and sound that repeat 40 times per second, affect the brain and whether they are safe. It is for healthy adults with normal memory and thinking skills. Participants visit MIT for one day, and some will have brain tests, memory and thinking tests, or blood tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can see and hear well enough for the light and sound stimulation and memory and thinking tests.
  • The study doctor believes you can complete the tests and other study steps.

Who can't join

  • Have had a seizure or have been diagnosed with epilepsy, a condition that causes seizures.
  • Have something that makes an MRI scan unsafe, such as a pacemaker, clips used to repair a bulging blood vessel, an artificial heart valve, an ear implant, or metal or other objects in your body.
  • The study doctor believes you cannot complete enough of the main study steps. The project director may allow exceptions after reviewing your case.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA