Fareon Open Label Device Clinical Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Fareon device
DeviceParticipants will use the device 2 times per week for 15 minutes at home.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Fareon DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 16Secondary outcomes
1
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 122
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 123
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 124
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 12Sponsors and contacts
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Source ClinicalTrials.gov
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