Status:
ACTIVE_NOT_RECRUITING
High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease
Lead Sponsor:
Massachusetts Institute of Technology
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-100 years
Phase:
NA
Brief Summary
Alzheimer's disease (AD) is characterized by significant memory loss and toxic protein deposits (amyloid and tau) in the brain. The investigators' lab found a non-invasive way to remove these toxic pr...
Detailed Description
It is known that Alzheimer's disease (AD) patients have significant disruptions in brain waves, especially the gamma frequency (\~30 - 100 Hz) waves. Recently, the investigators' lab found that gamma ...
Eligibility Criteria
Inclusion
- Subject is between the ages of 50 - 100.
- Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26.
- Subject 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.
Exclusion
- Subjects who do not have healthcare.
- Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
- Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
- Subjects with history of seizure or epilepsy within the past 24 months.
- 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 anti-epileptic agent.
- Subjects who have had a stroke within the past 24 months.
- Subjects diagnosed with migraine headache.
- 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 hearing or visual impairment.
- Subjects who have a life expectancy of less than 2 years.
- Subjects who are pregnant.
Key Trial Info
Start Date :
April 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04042922
Start Date
April 19 2019
End Date
April 30 2027
Last Update
October 1 2024
Active Locations (1)
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1
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139