Gamma Frequency Stimulation in Individuals With Down Syndrome
Down Syndrome
About this trial
This is an interventional supportive care trial for Down Syndrome focused on measuring Down Syndrome, Alzheimer Disease, Non-Invasive Sensory Stimulation, Light and Sound Stimulation, Gamma, Tactile Stimulation
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).
Sites / Locations
- Massachusetts Institute of TechnologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Sham Comparator
Experimental
Sham Comparator
Down Syndrome Experimental
Down Syndrome Sham
Cognitively Normal Experimental
Cognitively Normal Sham
Experimental arm within Down Syndrome participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Sham arm within the Down Syndrome participant group: exposure to control stimulation for 30-60 minutes.
Experimental arm within the cognitively normal control participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Sham arm within the cognitively normal control participant group: exposure to control stimulation for 30-60 minutes.