COMPLETED

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

Conditions

Post-Acute COVID-19 Syndrome Cognitive Dysfunction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-19

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06739668

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

David Putrino

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

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

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-12-19

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

Post-Acute COVID-19 Syndrome
Cognitive Dysfunction