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Fareon Open Label Device Clinical Trial

Not Yet RecruitingNA

Sponsor: Icahn School of Medicine at Mount Sinai

Conditions: Cognitive Dysfunction, Acquired Brain Injury, Traumatic Brain Injury

Interventions: Fareon device

Countries: United States

The purpose of this study is to assess the safety and feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to acquired brain injury, Long COVID, traumatic brain injury, myalgic encephalomyelitis (ME/CFS), and other neurodegenerative diagnoses including but not limited to Alzheimer's disease and to collect data on safety and efficacy to inform the design of larger clinical studies.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

New York, New York, United States