Light and Sound Stimulation for People With Down Syndrome

What Is This Study About?

Gamma waves are brain waves associated with focus and problem-solving. This study will test whether a device that delivers specific levels of light and sound to stimulate the brain can be used safely to increase brain gamma waves in people with Down syndrome. Down syndrome is characterized by an extra copy of chromosome 21, which increases the risk of Alzheimer's disease. Participants with and without Down syndrome will be randomly assigned to receive either gamma wave stimulation or a sham stimulation. Before and after brain stimulation, participants will complete cognitive testing to measure any changes in memory and cognitive performance and receive scans to measure any changes in brain wave activity. Throughout the study, all participants will be monitored for safety and tolerability. Future studies will address whether this type of intervention could be used to delay or treat Alzheimer's disease in people with Down syndrome.

Do I Qualify To Participate in This Study?

Must have:

• Diagnosis of Down syndrome or normal cognition
• If unable to provide informed consent, must have a legally authorized representative
• Medically stable with no change in medication for at least three months prior to study screening

Must NOT have:

• Diagnosis of mosaic form of Down syndrome
• Diagnosis of autism
• Recent diagnosis (less than six months) or untreated attention-deficit/hyperactivity disorder
• History of seizure, epilepsy, or stroke within the past two years
• History of migraine headaches
• Currently taking medications that could interfere with study, including:
  • Medications to treat epilepsy or that lower seizure threshold (e.g., bupropion, ciprofloxacin, and levofloxacin)
  • Psychiatric medications (e.g., antidepressants or antipsychotics)
• Serious risk of suicide or suicide attempt in the past year
• Behavioral problems such as aggression, agitation, and impulsivity that could interfere with study participation
• Any implanted device that may make the study procedure unsafe (e.g., implantable cardioverter defibrillator, deep brain stimulator, pacemaker, sacral nerve stimulator)
• Uncorrected, serious vision and hearing impairment
• Pregnancy

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Massachusetts
Massachusetts Institute of Technology Cambridge, MA 02139 Recruiting Gabrielle C de Weck, BS 617-258-7723 gdeweck@mit.edu

Who Sponsors This Study?

Lead: Massachusetts Institute of Technology

Source: ClinicalTrials.gov ID: NCT05196984