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

Not Applicable

Recruiting

• Conditions: Post-Acute COVID-19 Syndrome; Cognitive Dysfunction

• Registration Number: NCT06739668
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12-17
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Submitted: 2025-05-10
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Successfully Completed Treatments	End of treatment, 4 weeks	Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.

Secondary Outcome Measures

Name	Time	Method
Device comfort	End of treatment, 4 weeks	Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort.
Device ease of use	End of treatment, 4 weeks	Ease of use will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater ease of use.
Clarity of instructions	End of treatment, 4 weeks	Clarity of instructions will be assessed using a 5-point Likert scale, full scale from 1-5 with high scores indicating greater clarity of instructions.

Trial Locations

Locations (1)

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE); 🇺🇸 New York, New York, United States