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NCT05196984 · ClinicalTrials.gov registry record · NA
Gamma Frequency Stimulation in Individuals With Down Syndrome
A NA study of Down Syndrome, sponsored by Massachusetts Institute of Technology.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05196984: Recruiting NA study of Down Syndrome, sponsored by Massachusetts Institute of Technology.
NCT05196984 is a NA study of Down Syndrome that is actively recruiting participants, run by Massachusetts Institute of Technology. The registered enrollment target is 60 participants, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05196984, a NA study of Down Syndrome, is actively recruiting participants, sponsored by Massachusetts Institute of Technology.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Feasibility of gamma frequency stimulation in subjects with DS will be assessed by analyzing the EEG data from each subject for a sign of change in gamma frequency waves and determining the percent of subjects who show this change.
Conditions Studied
Interventions
- DEVICE GENUS device (Active Settings)
- DEVICE GENUS device (Sham Settings)
Study Locations (1)
Massachusetts
- Massachusetts Institute of Technology - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What NCT05196984 shows while recruiting
NCT05196984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Down Syndrome appearing as the primary indexed condition, and to 2 interventions - of which GENUS device (Active Settings) is the first listed.
NCT05196984 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05196984 about?
NCT05196984 is a clinical study titled "Gamma Frequency Stimulation in Individuals With Down Syndrome". 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 behavio...
What is the current status of trial NCT05196984?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2021-12-06. Estimated completion is 2025-12-31.
What conditions does trial NCT05196984 study?
This clinical trial studies the following conditions: Down Syndrome.
What interventions are being tested in trial NCT05196984?
The interventions under investigation include: GENUS device (Active Settings) (DEVICE), GENUS device (Sham Settings) (DEVICE).
Who is sponsoring clinical trial NCT05196984?
This trial is sponsored by Massachusetts Institute of Technology, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05196984 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Down Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05196984's enrollment target sits among peer trials
60 30th of 54 higher than 23 of 54 other Down Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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