Gamma Frequency Stimulation in Individuals With Down Syndrome

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT05196984
Status
Recruiting
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Conditions

  • Down Syndrome

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • GENUS device (Active Settings) — DEVICE
    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.
  • GENUS device (Sham Settings) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 6, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Feasibility of gamma frequency stimulation [ Time Frame: Immediately after the completion of stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Institute of TechnologyCambridgeMassachusetts02139
Ana Trisini Lipsanopoulos, BS
[email protected]
617-258-7723
Li-Huei Tsai, PhD (PRINCIPAL_INVESTIGATOR)
Ana Trisini Lipsanopoulos, BS (SUB_INVESTIGATOR)
Ute Geigenmuller, PhD (SUB_INVESTIGATOR)

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By research site
Massachusetts Institute of Technology· Cambridge, MA

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