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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
GENUS device (Active Settings)
DeviceParticipants 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)
DeviceParticipants 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.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Down Syndrome ExperimentalExperimental treatment 1 intervention
Group B: Down Syndrome ShamSham comparator 1 intervention
Group C: Cognitively Normal ExperimentalExperimental treatment 1 intervention
Group D: Cognitively Normal ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of gamma frequency 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.
Time frame
Immediately after the completion of stimulation2
Incidence of Stimulation-Related Adverse Events
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.
Time frame
Immediately after the completion of stimulationOther outcomes
1
Changes in memory and cognitive performance after gamma frequency stimulation
Exploratory measure to check if there is any change in cantab cognitive battery test performance between baseline and immediately after the completion of the stimulation. The cantab testing battery involves the Motor Screening Task (MOT), the Paired Associates Learning (PAL), the Reaction Time (RTI), and the Multitasking Test (MTT) to test for multitasking, episodic memory, executive function, and processing speed
Time frame
Baseline and immediately after the completion of the stimulationSponsors and contacts
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Source ClinicalTrials.gov