What this study is
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.
What's being tested
- Fareon device
Intervention · DEVICE
Participants will use the device 2 times per week for 15 minutes at home.
Study details
- Official title
- Microtesla Magnetic Therapy (MMT) Treatment of Cognitive Impairment: Open Label Pilot Study
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Cognitive Dysfunction · Acquired Brain Injury · Traumatic Brain Injury
- Enrolling
- 30 people
- Starts
- 2026-05-11
- Est. completion
- 2027-04-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 16 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States
Study team
Sponsor
Icahn School of Medicine at Mount Sinai
Study ID STUDY-26-00191
Principal investigator
David Putrino, PhD
Icahn School of Medicine at Mount Sinai
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.