Acquired Brain Injury, Cognitive Dysfunction, Traumatic Brain Injury
Conditions
Keywords
Long COVID, Myalgic encephalomyelitis/Chronic fatigue syndrome, Neurodegenerative, Alzheimer's disease
Brief 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 disease and to collect data on safety and efficacy to inform the design of larger clinical studies.
Interventions
DEVICEFareon device
Participants will use the device 2 times per week for 15 minutes at home.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
IncInclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * 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 * Individuals of childbearing age agreeing to use a highly effective form of birth control for the duration of their participation * Willing and able to sign informed consent or have a parent or LAR able to sign informed consent form * Willing and able to attend all study visits virtually or in person
Exclusion criteria
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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who complete prescribed device sessions | Week 12 and Week 16 | Device Completion Rate: Proportion of enrolled participants who complete ≥80% of prescribed device sessions over the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BrainCheck | Week 1 and Week 12 | 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. |
| Hospital Anxiety and Depression Scale (HADS) | Week 1 and Week 12 | 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. |
| PROMIS Sleep Disturbance | Week 1 and Week 12 | 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. |
| Neuro-QoL Cognitive Function (Short Form) | Week 1 and Week 12 | 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. |
| PROMIS Fatigue | Week 1 and Week 12 | 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. |
| Patient Global Impression of Change (PGIC) | Week 12 and Week 16 | 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"). |
| Functional Capacity Assessment (FUNCAP) | Week 1 and Week 12 and Week 16 | 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. |
Countries
United States
Contacts
CONTACTDavid Putrino, PhD
PRINCIPAL_INVESTIGATORDavid Putrino, PhD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed