Fareon Open Label Device Clinical Trial

NCT07600320 | Not Yet Recruiting

• 1 other identifier: STUDY-26-00191
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Dysfunction; Acquired Brain Injury; Traumatic Brain Injury

Keywords

Long COVID; Myalgic encephalomyelitis/Chronic fatigue syndrome; Neurodegenerative; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who complete prescribed device sessions

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

  Week 12 and Week 16

Secondary Outcomes (7)

• BrainCheck

  Week 1 and Week 12

• Hospital Anxiety and Depression Scale (HADS)

  Week 1 and Week 12

• PROMIS Sleep Disturbance

  Week 1 and Week 12

• Neuro-QoL Cognitive Function (Short Form)

  Week 1 and Week 12

• PROMIS Fatigue

  Week 1 and Week 12

Study Arms (1)

Fareon Device

EXPERIMENTAL

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

Device: Fareon device

Interventions

Fareon device DEVICE

Participants will use the device 2 times per week for 15 minutes at home.

Fareon Device

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Any sex/gender
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Brain Injuries; Brain Injuries, Traumatic; Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Neuromuscular Diseases; Dementia; Tauopathies; Neurodegenerative Diseases

Study Officials

• David Putrino, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Putrino, PhD

CONTACT

212-241-7658; CoreResearch@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An open-label study of 30 subjects with symptoms of cognitive impairment. Total study duration will be 16 weeks, including 12 weeks of treatment and 4 weeks of untreated follow up.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)