Clinical trial NCT06739668: Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction
Official title: Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Cognitive Dysfunction
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Humanity Neurotech Inc.
First posted: 2024-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization, 2:1, Active to Sham
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Successfully Completed Treatments
timeFrame: End of treatment, 4 weeks
Secondary outcomes:
measure: Device comfort
timeFrame: End of treatment, 4 weeks
measure: Device ease of use
timeFrame: End of treatment, 4 weeks
measure: Clarity of instructions
timeFrame: End of treatment, 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino
role: PRINCIPAL_INVESTIGATOR
References: