Gamma frequency stimulation for individuals with Down Syndrome
Acute Exposure of Individuals With Down Syndrome to Gamma Frequency Stimulation
This study is testing if a new light and sound treatment can help improve thinking skills and slow down Alzheimer's risk in people with Down Syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT05196984 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-65 with a clinically confirmed diagnosis of Down Syndrome.
Not a fit: Patients with dual diagnosis of Down Syndrome and Autism or those with a history of seizures or epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a novel non-invasive treatment that slows cognitive decline and improves memory in individuals with Down Syndrome.
How similar studies have performed: Initial pilot studies have shown promise in using similar gamma frequency stimulation methods in cognitively normal adults and those with mild Alzheimer's Disease.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Cambridge, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.