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

Mount Sinai Health System

Status: Enrolling

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

Treatments: Device: Sham Device; Device: Pascal device

Study type: Interventional

Funder types: Other

Identifiers

NCT06739668

STUDY-24-01276

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

Active device

Experimental group

Description:

The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm.

Treatment:

Device: Pascal device

Sham device

Sham Comparator group

Description:

The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm.

Treatment:

Device: Sham Device