Fareon Open Label Device Clinical Trial

Mount Sinai Health System

Status: Not yet enrolling

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

Treatments: Device: Fareon device

Study type: Interventional

Funder types: Other

Identifiers

NCT07600320

STUDY-26-00191

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Fareon Device

Experimental group

Description:

Participants 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

Treatment:

Device: Fareon device