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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Enrollment
30
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.
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.
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States
Proportion of Successfully Completed Treatments
Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.
Time frame: End of treatment, 4 weeks
Device comfort
Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort.
Time frame: End of treatment, 4 weeks
Device ease of use
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.
Time frame: End of treatment, 4 weeks
Clarity of instructions
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.
Time frame: End of treatment, 4 weeks
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