Gamma Frequency Stimulation in Individuals With Down Syndrome
Acute Exposure of Individuals With Down Syndrome to Gamma Frequency Stimulation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 25 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "In addition to the stimulation session, the investigators will also use electroencephalography (EEG) to check how the participant's brain waves respond to the stimulation, and use questionnaires to evaluate for safety and tolerability."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how light, sound, and vibration affect brain waves in adults ages 25–65 with Down syndrome. It also plans to enroll adults with normal thinking and memory as a comparison group. Researchers will check safety and thinking skills before and after a 30–60 minute light and sound session.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 25–65 years old.
- Have a doctor-confirmed diagnosis of Down syndrome. A chromosome test is optional.
- You or your legal guardian must agree to join and sign a consent form. If you cannot give consent, a legally authorized person must do so for you.
- Have stable health and consistent medicines for the past 3 months.
Who can't join
- Have mosaic Down syndrome, meaning only some cells have the extra chromosome, or have both Down syndrome and autism.
- Have had seizures, epilepsy, or a stroke in the past 24 months, or have a history of migraine headaches.
- Have attention-deficit/hyperactivity disorder (ADHD) that is untreated or was diagnosed less than 6 months ago.
- Take seizure medicines, mental health medicines such as antidepressants or antipsychotics, or medicines that raise seizure risk, such as Wellbutrin, ciprofloxacin, or levofloxacin.
- Have a serious risk of suicide or have attempted suicide in the past year.
- Have behavior problems, such as aggression, agitation, or acting without thinking, that could make it hard to follow study steps.
- Have an active medical device inside your body, such as a pacemaker, heart defibrillator, or brain or nerve stimulator.
- Have severe hearing or vision loss that has not been corrected, or are pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official 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).
Study sites (1)
MA
- Massachusetts Institute of Technology · Cambridge, MA 02139Ana Trisini Lipsanopoulos, BS · Study contact · 617-258-7723 · anat13@mit.eduLi-Huei Tsai, PhD · Principal investigatorAna Trisini Lipsanopoulos, BS · Sub-investigatorUte Geigenmuller, PhD · Sub-investigatorMore trials in Cambridge