RecruitingNot ApplicableNCT05196984

Gamma Frequency Stimulation in Individuals With Down Syndrome

Acute Exposure of Individuals With Down Syndrome to Gamma Frequency Stimulation

Sponsor

Massachusetts Institute of Technology

Enrollment

60 participants

Start Date

Dec 6, 2021

Study Type

INTERVENTIONAL

Conditions

Down Syndrome

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.

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria13

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).

Interventions

DEVICEGENUS 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.

DEVICEGENUS 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.