Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction (NCT06739668) | Clinical Trial Compass
CompletedNot Applicable
Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction
United States30 participantsStarted 2024-12-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.