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NCT Number: NCT07600320

Fareon Open Label Device Clinical Trial

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10029, United States

Location contact

David Putrino

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fareon device

Device

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

Primary outcomes

  1. Proportion of participants who complete prescribed device sessions

    Time frame: Week 12 and Week 16

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

Secondary outcomes

  1. BrainCheck

    Time frame: Week 1 and Week 12

    BrainCheck is a computerized cognitive assessment battery evaluating attention, executive function, memory, and processing speed. Individual task scores are combined to generate a composite cognitive score that is normalized against age-adjusted reference populations. Composite score from 0-200. Higher scores indicate better cognitive performance. Change in composite score from baseline to Week 12 will be evaluated.

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Week 1 and Week 12

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire assessing symptoms of anxiety and depression. Each item is scored from 0 to 3. The measure generates separate anxiety (HADS-A) and depression (HADS-D) subscale scores ranging from 0-21, and a total score ranging from 0-42. Higher scores indicate greater symptom severity.

  3. PROMIS Sleep Disturbance

    Time frame: Week 1 and Week 12

    The PROMIS Sleep Disturbance measure assesses perceived sleep quality and sleep-related impairment. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate greater sleep disturbance.

  4. Neuro-QoL Cognitive Function (Short Form)

    Time frame: Week 1 and Week 12

    The Neuro-QoL Cognitive Function short form assesses perceived cognitive abilities in everyday life. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 relative to the reference population. Higher scores indicate better perceived cognitive function.

  5. PROMIS Fatigue

    Time frame: Week 1 and Week 12

    The PROMIS Fatigue measure assesses fatigue severity and the impact of fatigue on daily functioning. Raw scores are converted to standardized T-scores with a mean of 50 and a standard deviation of 10 relative to the reference population. Higher scores indicate greater fatigue.

  6. Patient Global Impression of Change (PGIC)

    Time frame: Week 12 and Week 16

    The Patient Global Impression of Change (PGIC) is a single-item measure assessing participants' perception of overall change in their condition since starting treatment. Responses are rated on a 7-point Likert scale ranging from 1 ("very much improved") to 7 ("very much worse").

  7. Functional Capacity Assessment (FUNCAP)

    Time frame: Week 1 and Week 12 and Week 16

    The Functional Capacity Assessment (FUNCAP-27) is a 27-item questionnaire assessing functional capacity across multiple domains of daily activity. Each item is scored on a 7-point scale from 0 to 6, where 0 indicates inability to perform the activity and 6 indicates no limitation. Item scores are summed to generate a total score ranging from 0 to 162, with higher scores indicating better functional capacity.

Study contacts

Contact information is provided by the study sponsor or research team.

David Putrino, PhD

CONTACT

[email protected]

212-241-7658

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Microtesla Magnetic Therapy (MMT) Treatment of Cognitive Impairment: Open Label Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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