Acute Exposure of Individuals With Down Syndrome to Gamma Frequency Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: t
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• Subject is between the ages of 25-65

• Subject must have a clinically confirmed diagnosis of Down Syndrome (karyotypes optional). Individuals with mosaic Down syndrome will be excluded.

• Subject or their legal guardian is willing to sign informed consent document.

• If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.

• Subject will be medically stable with consistent medication over the previous 3 months.

Locations
United States
Massachusetts
Massachusetts Institute of Technology
RECRUITING
Cambridge
Contact Information
Primary
MJ Quay, MS
mcolburn@mit.edu
6172587723
Time Frame
Start Date: 2021-12-06
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Down Syndrome Experimental
Experimental arm within Down Syndrome participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Sham_comparator: Down Syndrome Sham
Sham arm within the Down Syndrome participant group: exposure to control stimulation for 30-60 minutes.
Experimental: Cognitively Normal Experimental
Experimental arm within the cognitively normal control participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Sham_comparator: Cognitively Normal Sham
Sham arm within the cognitively normal control participant group: exposure to control stimulation for 30-60 minutes.
Authors
Vanesa Fernandez
Sponsors
Leads: Massachusetts Institute of Technology

This content was sourced from clinicaltrials.gov