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

Age: 18 - 65 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: December 18, 2024

Contact Information:
929-656-5267
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:

 

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