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Fareon Device for Cognitive Dysfunction after Brain Injury

This study is testing the Fareon device, an at-home treatment for cognitive dysfunction (problems with thinking, memory, and attention). It's for people aged 16 and older who speak English and have cognitive issues from conditions like Long COVID, traumatic brain injury, or other acquired brain injuries. The main goal is to see if people can safely and consistently use the Fareon device at home. This information will help researchers plan larger studies in the future. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an open-label study, meaning you and the researchers will know you are receiving the Fareon device. It plans to enroll 30 participants.
What's involved
You would use the Fareon device at home 2 times per week for 15 minutes. The study will track your use for 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your participation will be tracked for 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07600320

Fareon Open Label Device Clinical Trial

Not Yet Recruiting
NAAges 16+Interventional
Icahn School of Medicine at Mount Sinai
~30 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Fareon device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who complete prescribed device sessions
Measured over Week 12 and Week 16

Conditions

Cognitive Dysfunction
Acquired Brain Injury
Traumatic Brain Injury

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Alzheimer's DiseaseBrain InjuryChronic Fatigue SyndromeCognitive DysfunctionDegenerative Disease of Nervous System, UnspecifiedPost-Acute Sequelae of COVID-19Traumatic Encephalopathy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • David Putrino, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

David Putrino, PhD
[email protected]
212-241-7658
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of participants who complete prescribed device sessionsWeek 12 and Week 16

    Device Completion Rate: Proportion of enrolled participants who complete ≥80% of prescribed device sessions over the study period.