Gamma Frequency Stimulation in Individuals With Down Syndrome

ConditionDown Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorMassachusetts Institute of Technology

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 4 treatment groups