Using a neurotech device to help adults with cognitive issues from long COVID

Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study

This study is testing whether an at-home neurotechnology device can help adults with cognitive issues caused by long COVID feel better over eight weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06739668 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of an at-home neurotechnology treatment for adults experiencing cognitive dysfunction related to post-acute COVID-19 syndrome (PASC). It involves a prospective randomized controlled design with 30 participants over an 8-week period, which includes 4 weeks of treatment with the Pascal device and 4 weeks of follow-up without treatment. The study aims to gather data on the safety and efficacy of the device to inform future larger clinical trials.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced cognitive impairment due to long COVID for at least 6 months.

Not a fit: Patients with pre-existing cognitive dysfunction prior to COVID-19 infection or those currently enrolled in another clinical trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve cognitive function in patients suffering from long COVID-related cognitive dysfunction.

How similar studies have performed: While this approach is novel, similar studies targeting cognitive dysfunction in post-COVID patients are emerging, but definitive success has yet to be established.

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

Where this trial is running

New York, New York

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

Study contacts

• Principal investigator: David Putrino — Icahn School of Medicine at Mount Sinai
• Study coordinator: Mackenzie Doerstling

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