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Not yet recruiting NCT07600320

Fareon Open Label Device Clinical Trial

No phase Interventional Cognitive Dysfunction Acquired Brain Injury Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fareon device.
Who it may be relevant to
Registry conditions: Cognitive Dysfunction, Acquired Brain Injury, Traumatic Brain Injury. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of participants who complete prescribed device sessions [Time frame: Week 12 and Week 16]
Secondary outcome measures (7)
  • BrainCheck [Time frame: Week 1 and Week 12]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: Week 1 and Week 12]
  • PROMIS Sleep Disturbance [Time frame: Week 1 and Week 12]
  • Neuro-QoL Cognitive Function (Short Form) [Time frame: Week 1 and Week 12]
  • PROMIS Fatigue [Time frame: Week 1 and Week 12]
  • Patient Global Impression of Change (PGIC) [Time frame: Week 12 and Week 16]
  • Functional Capacity Assessment (FUNCAP) [Time frame: Week 1 and Week 12 and Week 16]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) — New York

Identifiers

NCT: NCT07600320 · STUDY-26-00191

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗