Fareon Open Label Device Clinical Trial
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT07600320
- Status
- Not Yet Recruiting
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Conditions
- Acquired Brain Injury
- Cognitive Dysfunction
- Traumatic Brain Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fareon device — DEVICEParticipants will use the device 2 times per week for 15 minutes at home.
Study Details
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.
Key Dates
- Start date
- May 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: 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
Primary Outcome Measure
Proportion of participants who complete prescribed device sessions [ Time Frame: Week 12 and Week 16 ]
Central Contacts
- David Putrino, PhD212-241-7658
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) | New York | New York | 10029 | David Putrino (PRINCIPAL_INVESTIGATOR) |
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