Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction

Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study

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 Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Device: Pascal device; Device: Sham Device

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Humanity Neurotech Inc.
• Investigators: Principal Investigator: David Putrino, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Mental Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Neurocognitive Disorders; Lung Diseases; Cognition Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome; Cognitive Dysfunction
• Other Study ID Numbers: STUDY-24-01276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No