NCT05196984 Gamma Frequency Stimulation in Individuals With Down Syndrome
| NCT ID | NCT05196984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts Institute of Technology |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-12-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-12-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Li-Huei Tsai, PhD
PRINCIPAL INVESTIGATOR
Massachusetts Institute of Technology
Frequently Asked Questions
Who can join the NCT05196984 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05196984 currently recruiting?
Yes, NCT05196984 is actively recruiting participants. Contact the research team at gamma.wave@mit.edu for enrollment information.
Where is the NCT05196984 trial being conducted?
This trial is being conducted at Cambridge, United States.
Who is sponsoring the NCT05196984 clinical trial?
NCT05196984 is sponsored by Massachusetts Institute of Technology. The principal investigator is Li-Huei Tsai, PhD at Massachusetts Institute of Technology. The trial plans to enroll 60 participants.