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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Dec 17, 2024

Keywords

ClinConnect Summary

The Humanity Neurotech Device Clinical Trial is looking into a new treatment for adults experiencing cognitive problems related to Long COVID, which is also known as Post-Acute COVID-19 Syndrome (PASC). The study aims to see if this treatment can safely help improve thinking and memory skills over an 8-week period. It will involve 30 participants who have had PASC symptoms for at least 6 months and are experiencing moderate to severe cognitive difficulties. Participants will receive 4 weeks of treatment with the device at home, followed by 4 weeks of follow-up without treatment.

To be eligible for this trial, participants need to be at least 18 years old, speak English, and have had a confirmed COVID-19 infection at least 6 months prior to joining. They should also have noticeable cognitive impairment based on specific tests. However, people with certain medical histories, such as previous cognitive issues, or who are currently taking specific medications, may not qualify. This trial is currently recruiting participants, and those who join can expect to contribute to important research that could lead to better treatments for cognitive dysfunction after COVID-19.

Gender

ALL

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