Recruiting

Gamma Frequency Stimulation

Sponsor:

Massachusetts Institute of Technology

Code:

NCT05196984

Conditions

Down Syndrome

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

GENUS device (Active Settings)

GENUS device (Sham Settings)

Study Details

Brief 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

Down Syndrome

Study ID

NCT05196984

Start date

Dec 6, 2021

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Down Syndrome Experimental

Experimental arm within Down Syndrome participant group: exposure to active 40Hz stimulation for 30-60 minutes.

sham comparator: Down Syndrome Sham

Sham arm within the Down Syndrome participant group: exposure to control stimulation for 30-60 minutes.

experimental: Cognitively Normal Experimental

Experimental arm within the cognitively normal control participant group: exposure to active 40Hz stimulation for 30-60 minutes.

sham comparator: Cognitively Normal Sham

Sham arm within the cognitively normal control participant group: exposure to control stimulation for 30-60 minutes.

Interventions

GENUS device (Active Settings)

Participants in the active condition within the Down Syndrome participant group and the Cognitively Normal Control group will use the GENUS device configured to active 40Hz settings for 30-60 minutes.

GENUS device (Sham Settings)

Participants in the control condition within the Down Syndrome participant group and the Cognitively Normal Control group will use the GENUS device configured to sham settings for 30-60 minutes.

Primary outcome measure

  • Feasibility of gamma frequency stimulation [ Time Frame: Immediately after the completion of stimulation ]
  • Incidence of Stimulation-Related Adverse Events [ Time Frame: Immediately after the completion of stimulation ]

Central Contacts and Locations

Central contacts

gamma wave, BS

6172587723gamma.wave@mit.edu

Ana Trisini Lipsanopoulos, BS

6172587723anat13@mit.edu

Locations

Massachusetts Institute of Technology

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Ana Trisini Lipsanopoulos, BS

617-258-7723anat13@mit.edu

Principal Investigator:

Li-Huei Tsai, PhD

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • Down Syndrome
  • Alzheimer Disease
  • Non-Invasive Sensory Stimulation
  • Light and Sound Stimulation
  • Gamma
  • Tactile Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2026-03-31.