NCT05196984 · RECRUITING
Gamma Frequency Stimulation in Individuals With Down Syndrome
This trial tests a non-drug device called GENUS that delivers flickering light, sound, and vibration at a specific brain frequency called gamma. Researchers want to see whether this stimulation is safe and feasible in people with Down syndrome, and whether it changes brain wave patterns or cognitive performance. It is a small Phase NA exploratory study — think of it as early-stage testing to see if the approach even makes sense in this population, not a proven treatment.
You may qualify if
- 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.
You're excluded if
- 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).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-31