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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Post-Acute COVID-19 Syndrome
Intervention / Treatment

-

Contacts and Locations

New York

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

David Putrino, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-12-31