Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction
NCT ID: NCT06739668
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-12-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
QUADRUPLE
Study Groups
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Active device
The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm.
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 device
The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm.
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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Humanity Neurotech Inc.
UNKNOWN
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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David Putrino
Professor
Principal Investigators
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David Putrino
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States
Countries
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Other Identifiers
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STUDY-24-01276
Identifier Type: -
Identifier Source: org_study_id