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 — DEVICE
    Participants 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 Device
    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

Primary Outcome Measure

Proportion of participants who complete prescribed device sessions [ Time Frame: Week 12 and Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)New YorkNew York10029
David Putrino (PRINCIPAL_INVESTIGATOR)

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