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

Completed · Not applicable · Has a placebo group

Conditions studied: Post-Acute COVID-19 Syndrome, Cognitive Dysfunction

In brief

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.

Key facts

Study ID

NCT06739668

Run by

Icahn School of Medicine at Mount Sinai

People needed

30

Starts

2024-12-19

Expected to finish

2025-12-01

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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