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Gamma Frequency Stimulation in Individuals With Down Syndrome

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 31, 2025 to Dec 31, 2026 Completion date: Dec 31, 2025 to Dec 31, 2026 · Site contact updatedv7 Show 2 more changesShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2026
    • Site contact updated
  2. Primary completion date: Jun 1, 2025 to Oct 31, 2025v6
  3. Primary completion date: Jun 1, 2024 to Jun 1, 2025 Completion date: Dec 31, 2024 to Dec 31, 2025 · Site contact updatedv5 Show 2 more changesShow less
    • Completion date: Dec 31, 2024 to Dec 31, 2025
    • Site contact updated
  4. Primary completion date: Sep 1, 2023 to Jun 1, 2024 Completion date: Oct 31, 2024 to Dec 31, 2024 · Site contact updatedv4 Show 2 more changesShow less
    • Completion date: Oct 31, 2024 to Dec 31, 2024
    • Site contact updated
  5. Enrollment target: 30 to 60 Primary completion date: Sep 2022 to Sep 1, 2023 · Completion date: Oct 31, 2022 to Oct 31, 2024 · Study description expanded, about 108 words · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Sep 2022 to Sep 1, 2023
    • Completion date: Oct 31, 2022 to Oct 31, 2024
    • Study description expanded, about 108 words
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary endpoints: 3 to 2v2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05196984
Lead Sponsor Massachusetts Institute of Technology
Conditions Down Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov