An interventional study of Fareon device in Cognitive Dysfunction, Acquired Brain Injury and Traumatic Brain Injury, sponsored by Icahn School of Medicine at Mount Sinai. Not yet recruiting at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Other
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.
IncInclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
Individual who meets any of the following criteria will be excluded from participation in this study:
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
Device: Fareon device
Participants will use the device 2 times per week for 15 minutes at home.
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.
Time frame: Week 12 and Week 16
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: 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.
Time frame: Week 1 and Week 12 and Week 16
Plan to share: No
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai