Cognitive Dysfunction, Post-Acute COVID-19 Syndrome
Conditions
Brief summary
The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.
Interventions
DEVICEPascal device
The study devices consist of a tabletop Console with user interface and a head-worn applicator (Headset) that is connected via coaxial cable. The Headset is positioned on the head per instructions, and then the study subject powers on the device by pressing the power button and initiates a 15-minute treatment by pressing the start button. LED lights on the console count down during the treatment to indicate time remaining and, once the treatment is complete, the device automatically powers off.
DEVICESham Device
The sham device will look identical to the active device and will have the same indicator lights and sounds, but will not emit magnetic field therapy.
Sponsors
Icahn School of Medicine at Mount Sinai
Humanity Neurotech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomization, 2:1, Active to Sham
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * English Speaking * SARS CoV-2 infection as documented by laboratory nucleic acid amplification test or antibody test ≥ 6 months from screening or signed attestation of positive test result * Experiencing PASC symptoms ≥ 6 months * Objective cognitive impairment on neuropsychological measures (as defined by a z-score ≥1 standard deviation below the normative mean) in executive functioning * Individuals of childbearing age agreeing to use a highly effective form of birth control
Exclusion criteria
* History of cognitive dysfunction present prior to SARS CoV-2 infection * Febrile (\> 99 F) at the time of the enrollment visit * Enrollment in another interventional clinical trial in the last 90 days or during the study period * Recent SARS CoV-2 reinfection in the last 30 days or during the study period * Recent SARS CoV-2 vaccination in the last 30 days or plans to be vaccinated during the 8 week study period * Currently taking immunomodulatory medication on an ongoing basis (NSAIDs, corticosteroids, cytokine antagonists, IVIG) * History of bipolar disorder, psychotic disorder, substance use disorder * Change in anti-depressant or other psychoactive medication or dose in the last 90 days * Cranially implanted devices or metal * Any serious unstable medical or neurologic condition * History of severe head injury (as defined by loss of consciousness for ≥30 minutes) or stroke in the past 12 months * Pregnant or plan to become pregnant during the study as indicated by positive pregnancy test * Serious immune/autoimmune diagnoses prior to SARS-CoV-2 infection * ME/CFS diagnosis prior to first SARS-CoV-2 infection * Existing diagnosis of Post-treatment Lyme Disease Syndrome * Inability to achieve appropriate positioning of the study device on the head
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Successfully Completed Treatments | End of treatment, 4 weeks | Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device ease of use | End of treatment, 4 weeks | Ease of use will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater ease of use. |
| Clarity of instructions | End of treatment, 4 weeks | Clarity of instructions will be assessed using a 5-point Likert scale, full scale from 1-5 with high scores indicating greater clarity of instructions. |
| Device comfort | End of treatment, 4 weeks | Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Putrino
Icahn School of Medicine at Mount Sinai
Outcome results
None listed