RecruitingNot ApplicableNCT05196984

Gamma Frequency Stimulation in Individuals With Down Syndrome

Acute Exposure of Individuals With Down Syndrome to Gamma Frequency Stimulation

Sponsor

Massachusetts Institute of Technology

Enrollment

60 participants

Start Date

Dec 6, 2021

Study Type

INTERVENTIONAL

Conditions

Down Syndrome

Summary

Down Syndrome (DS) is characterized by an additional copy of chromosome 21, which also increases risk of Alzheimer's Disease (AD). The investigators' lab found a non-invasive way to remove toxic proteins from the brain in AD mouse models. Remarkably, treated mice also have improved memory on behavioral testing. The investigators then translated this non-invasive method, which uses light and sound to stimulate the brain, to be used in mild Alzheimer's patients and cognitively normal adults. The investigators have also translated this research into a vibrating speaker device to study tactile vibration to stimulate the brain as well. For the present study, 30 participants with Down Syndrome and 30 cognitively normal adult controls will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) during light, sound, and tactile stimulation. The investigators will also test for safety, feasibility, and cognitive performance before and after a 30-60 minute session of light and sound stimulation to optimize the stimulation devices for use in the DS population.

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a specific type of light and sound stimulation (at a frequency called gamma, 40Hz) can improve brain function and cognitive symptoms in adults with Down syndrome. **You may be eligible if...** - You are between 25 and 65 years old - You have a confirmed diagnosis of Down syndrome (not mosaic Down syndrome) - You have been on stable medications for at least 3 months - You or your legal guardian are able to provide consent **You may NOT be eligible if...** - You have both Down syndrome and autism - You have had a seizure or epilepsy in the past 2 years - You were recently (within the last 6 months) diagnosed with ADHD Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGENUS device (Active Settings)

Participants in the active condition within the Down Syndrome participant group and the Cognitively Normal Control group will use the GENUS device configured to active 40Hz settings for 30-60 minutes.

DEVICEGENUS device (Sham Settings)

Participants in the control condition within the Down Syndrome participant group and the Cognitively Normal Control group will use the GENUS device configured to sham settings for 30-60 minutes.