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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomization, 2:1, Active to Sham
Primary Purpose
Device Feasibility
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active device 		The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm.
  • 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.
Sham Comparator
Sham device 		The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm.
  • 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.

Recruiting Locations

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York 10029
Contact:
CoreResearch@mountsinai.org

More Details

NCT ID
NCT06739668
Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Mackenzie Doerstling
212-241-8454
CoreResearch@mountsinai.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.