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| Name | Class |
|---|---|
| Humanity Neurotech Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active device | Experimental | The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm. |
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| Sham device | Sham Comparator | The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pascal device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Successfully Completed Treatments | Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments. | End of treatment, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Device comfort | Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Putrino | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) | New York | New York | 10029 | United States |
No plan to share IPD.
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Randomization, 2:1, Active to Sham
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| Sham Device | 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. |
|
| 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. | End of treatment, 4 weeks |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |