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

NCT06739668 | Completed FDA Device

• 1 other identifier: STUDY-24-01276
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Post-Acute COVID-19 Syndrome; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Device comfort

  End of treatment, 4 weeks

• Device ease of use

  End of treatment, 4 weeks

• Clarity of instructions

  End of treatment, 4 weeks

Study Arms (2)

Active device

EXPERIMENTAL

The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm.

Device: Pascal device

Sham device

SHAM COMPARATOR

The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm.

Device: Sham Device

Interventions

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.

Active device

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.

Sham device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Humanity Neurotech Inc.: collaborator

Study Sites (1)

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Putrino

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization, 2:1, Active to Sham

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 18, 2024
• Study Start: December 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)