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Gamma Frequency Stimulation for Down Syndrome

This study is looking at a new way to potentially help people with Down Syndrome. Researchers are testing a device called GENUS that uses light and sound, or a vibrating speaker, to stimulate the brain. This stimulation, called gamma frequency stimulation, has shown promise in removing harmful proteins and improving memory in animal studies of Alzheimer's disease, which is more common in people with Down Syndrome. The study wants to see if the GENUS device is safe and practical to use. You might be able to join if you are between 25 and 65 years old and have a confirmed diagnosis of Down Syndrome. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 60 participants, including individuals with Down Syndrome and cognitively normal controls. Participants will be assigned to either an active GENUS device setting or a sham (inactive) setting.
What's involved
Participants will use the GENUS device for 30-60 minutes. The study will measure feasibility and adverse events immediately after stimulation.
Compensation
Not stated in the trial record.
Follow-up
Feasibility and adverse events are measured immediately after the completion of stimulation, so there is no extended follow-up period specified.

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NCT05196984

Gamma Frequency Stimulation in Individuals With Down Syndrome

Recruiting
NAAges 25–65InterventionalSupportive care
Massachusetts Institute of Technology
~60 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:GENUS device (Active Settings)GENUS device (Sham Settings)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of gamma frequency stimulation
Measured over Immediately after the completion of stimulation
+1 more outcome measured

Conditions

Down Syndrome

Explore related trials

Down Syndrome

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Li-Huei Tsai, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts Institute of Technology

Who to contact

gamma wave, BS
[email protected]
6172587723
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject is between the ages of 25-65
Subject must have a clinically confirmed diagnosis of Down Syndrome (karyotypes optional). Individuals with mosaic Down syndrome will be excluded.
Subject or their legal guardian is willing to sign informed consent document.
If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.
Subject will be medically stable with consistent medication over the previous 3 months.

Exclusion

Subjects has history of a dual diagnosis Down Syndrome and Autism
Subjects with has history of seizure or epilepsy within the past 24 months.
Subjects with a new diagnosis of Attention-deficit/hyperactivity disorder (ADHD) (\< 6 months) or untreated ADHD
Active treatment with one or more anti-epileptic agent.
Subjects who have a known history a stroke within the past 24 months.
Subjects with a known history of migraine headache.
Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
Subjects who have profound and uncorrected hearing or visual impairment.
Subjects who are pregnant (self-report).

What this trial measures

  • Feasibility of gamma frequency stimulationImmediately after the completion of stimulation

    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.

  • Incidence of Stimulation-Related Adverse EventsImmediately after the completion of stimulation

    Tolerability and safety of gamma frequency stimulation will be assessed using questionnaires and measures to rate the subjects' overall experience with the stimulation. These questionnaires will monitor for any adverse effects of the stimulation.