Gamma frequency stimulation for individuals with Down Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of non-invasive gamma frequency stimulation using light and sound on individuals with Down Syndrome, who are at increased risk for Alzheimer's Disease. The research aims to assess the safety, feasibility, and cognitive performance of this stimulation method by recruiting 30 participants with Down Syndrome and 30 cognitively normal adult controls. Participants will undergo brain wave assessments using electroencephalogram (EEG) during the stimulation sessions. The goal is to determine if this approach can modify disease progression and improve cognitive function in this population.

Why it matters

Who can join: the full rules

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).

Where it's running

• Massachusetts Institute of Technology
  Cambridge, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Li-Huei Tsai, PhD — Massachusetts Institute of Technology
• Study coordinator: gamma wave, BS
• Email: gamma.wave@mit.edu
• Phone: 6172587723

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Thymus removal and immune aging in people with Down syndrome

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.