The purpose of this study is to assess the safety and feasibility of an at-home MMTtreatment in patients with cognitive dysfunction related to acquired brain injury, LongCOVID, traumatic brain injury, myalgic encephalomyelitis (ME/CFS), and otherneurodegenerative diagnoses including but not limited to Alzheimer's disease and tocollect data on safety and efficacy to inform the design of larger clinical studies.
Not Provided
Device: Fareon device
Participants will use the device 2 times per week for 15 minutes at home.
IncInclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
- Any sex/gender
- 16 years of age or older
- English Speaking
- Experiencing symptoms of at least self-reported mild cognitive impairment associated
with a confirmed diagnosis of a condition such as Long COVID, Traumatic Brain
Injury, other Acquired Brain Injuries, and other neurodegenerative diagnoses
including but not limited to Alzheimer's disease
- Individuals of childbearing age agreeing to use a highly effective form of birth
control for the duration of their participation
- Willing and able to sign informed consent or have a parent or LAR able to sign
informed consent form
- Willing and able to attend all study visits virtually or in person
Exclusion Criteria:
Individual who meets any of the following criteria will be excluded from participation in
this study:
- Enrollment in another interventional clinical trial in the last 90 days or during
the study period
- Change in anti-depressant or other psychoactive medication or dose in the last 90
days
- Cranially implanted devices or metal
- Pacemaker
- History of seizure disorder
- Pregnant or plan to become pregnant during the study as indicated by proof of a
positive pregnancy test
- Inability to achieve appropriate positioning of the study device on the head
- Any medical, psychiatric, or neurological condition, or concurrent treatment, that
in the opinion of the Principal Investigator would interfere with study
participation, interpretation of results, or pose additional risk to the
participant.
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States
Investigator: David Putrino
David Putrino, PhD
212-241-7658
CoreResearch@mountsinai.org
David Putrino, PhD, Principal Investigator
Icahn School of Medicine at Mount Sinai