The purpose of this study is to assess the feasibility of an at-home MMT treatment inpatients with cognitive dysfunction related to PASC, and to collect data on safety andefficacy to inform the design of larger clinical studies. A prospective randomizedcontrolled study of 30 participants with PASC and moderate to severe cognitivedysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4weeks of untreated follow up.
Not Provided
Device: Pascal 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.
Device: Sham 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.
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
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States
Mackenzie Doerstling
212-241-8454
CoreResearch@mountsinai.org
David Putrino, Principal Investigator
Icahn School of Medicine at Mount Sinai