Status:
RECRUITING
Gamma Frequency Stimulation in Individuals With Down Syndrome
Lead Sponsor:
Massachusetts Institute of Technology
Conditions:
Down Syndrome
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
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 prote...
Detailed Description
The hallmark sign of Down Syndrome (DS) is an additional copy of chromosome 21, which is also a risk factor of Alzheimer's Disease (AD). Given the significantly increased likelihood of developing AD i...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05196984
Start Date
December 6 2021
End Date
December 31 2025
Last Update
September 25 2025
Active Locations (1)
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1
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139