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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 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.

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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.

Conditions Studied

Interventions

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

Study Locations (1)

Massachusetts

  • Massachusetts Institute of Technology - Cambridge

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-12-06
Est. Completion 2025-12-31
Phase NA

What the Registry Record Tells You About NCT05196984

The ClinicalTrials.gov registry entry for NCT05196984 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (98% lower). The listed sponsor is Massachusetts Institute of Technology, which has 24 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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