Could flickering lights and tones boost brain health in down syndrome?
NCT ID NCT05196984
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study explores whether a non-invasive method using light, sound, and vibration can safely change brain activity in adults with Down syndrome. Researchers will measure brain waves and check for side effects during a single 30-60 minute session. The goal is to see if this approach is feasible and safe before testing it for potential cognitive benefits.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts Institute of Technology
RECRUITINGCambridge, Massachusetts, 02139, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A simple blood draw could one day detect down syndrome in pregnancy
- Could hidden blood problems be common in children with certain genetic syndromes?
- Can a simple checklist predict how well dental treatment will go for people with down syndrome?
- Eye scans could spot hidden vision risk in down syndrome
- Playtime as brain training: a new approach targets thinking skills in down syndrome