Cognitive DysfunctionNCT07600320
Fareon Open Label Device Clinical Trial
A study testing Fareon device in people with Cognitive Dysfunction and Acquired Brain Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cognitive Dysfunction, Acquired Brain Injury, Traumatic Brain Injury
- What is being tested?
- Fareon device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, 10029
David Putrino
About this study
Official title: Microtesla Magnetic Therapy (MMT) Treatment of Cognitive Impairment: Open Label Pilot Study
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.
- Being tested
- Fareon device
- Keywords
- Long COVID, Myalgic encephalomyelitis/Chronic fatigue syndrome, Neurodegenerative, Alzheimer's disease
- Medical subject headings
- Cognitive Dysfunction, Brain Injuries, Brain Injuries, Traumatic, Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fareon deviceDevice
Participants will use the device 2 times per week for 15 minutes at home.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Fareon device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12 and Week 16
Secondary outcomes (7)
BrainCheck
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.
Measured: Week 1 and Week 12
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Week 1 and Week 12
PROMIS Sleep Disturbance
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.
Measured: Week 1 and Week 12
Neuro-QoL Cognitive Function (Short Form)
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.
Measured: Week 1 and Week 12
PROMIS Fatigue
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.
Measured: Week 1 and Week 12
Patient Global Impression of Change (PGIC)
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").
Measured: Week 12 and Week 16
Functional Capacity Assessment (FUNCAP)
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.
Measured: Week 1 and Week 12 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600320
- Sponsor's protocol ID
- STUDY-26-00191
- Status last verified
- Mar 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microtesla Magnetic Therapy (MMT) Treatment of Cognitive Impairment: Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT07600320
- Acronym / sponsor ID
- STUDY-26-00191
- Keywords
- Long COVID, Myalgic encephalomyelitis/Chronic fatigue syndrome, Neurodegenerative, Alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fareon Device | Experimental | Device: Fareon deviceParticipants 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fareon deviceParticipants will use the device 2 times per week for 15 minutes at home. | Device | Fareon Device |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Putrino, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fareon device in people with Cognitive Dysfunction and Acquired Brain Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Putrino, PhD (212-241-7658, CoreResearch@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who complete prescribed device sessions (time frame: Week 12 and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.