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NCT05196984

Gamma Frequency Stimulation in Individuals With Down Syndrome

Recruiting now NA Last updated 31 March 2026
What this trial tests

NA trial testing GENUS device (Active Settings) in Down Syndrome in 60 participants. Currently enrolling.

Timeline
6 December 2021
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorMassachusetts Institute of Technology
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment60
Start date6 December 2021
Primary completion31 December 2026
Estimated completion31 December 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts Institute of Technology

Who can join

Adults 25 to 65, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Audiovisual gamma stimulation for the treatment of neurodegeneration.
    Blanco-Duque C, Chan D, Kahn MC, Murdock MH, et al · · 2024 · cited 42× · PMID 38115692 · DOI 10.1111/joim.13755

Verify or expand the search:

Other trials of GENUS device (Active Settings)

Trials testing the same drug.

Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

Other Massachusetts Institute of Technology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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