Neural and Cognitive Consequences of COVID-19 Survival

Recruiting

• Conditions: COVID-19; Brain Fog; Memory Deficits; COVID Long-Haul; COVID-19 Pandemic; Fatigue; Concentration Ability Impaired
• Interventions: Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)

• Registration Number: NCT06208943
• Lead Sponsor: San Francisco Veterans Affairs Medical Center

Brief Summary

The novel coronavirus SARS-CoV-2 infection, COVID, continues to rage throughout the world with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). This translates to millions of people surviving COVID19 infection. While the lungs are ground zero, COVID tears through organ systems from brain to blood vessels. We are now beginning to see people recover but complain of ongoing problems, including lingering cognitive problems, depression, and anxiety. We have brought together 2 laboratories with complementary techniques including psychological testing and neuroimaging methods togethers with markers in the blood that may signal damage in the brain. A close look at these problems is timely and imperative if we are to understand the pathophysiology of 'COVID brain' and prepare for downstream problems.

Detailed Description

The SARS-CoV-2 pandemic has been going on for over a year worldwide, with 115,000,000 confirmed cases and over 2,500,000 deaths (as of Mar 3, 2021). We are seeing people recover from the initial COVID infection with complaints of ongoing problems. An increasing number of people are complaining of cognitive deficits and depression/anxiety.

Methodologically, we have brought together two laboratories studying neurocognitive impairment using an EEG, MRI, and behavioral approach as well as laboratory-based data. This study queries neuropsychological functions in individuals using a neuropsychological battery, EEG-based measures, functional MRI (connectivity) and structural MRI (gray and white matter volumes, myelin, micro-bleeds). In addition, we have preliminary data to show a continued increase in plasma cytokines in COVID survivors. Plasma isolated neuronal enriched extracellular vesicles (nEVs) showed an increase in amyloid beta, neurofilament light and pT181-Tau, all proteins associated with neurodegeneration.

The overall aim is to determine the extent of cognitive, clinical, and neurological damage in people recovered from COVID.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Our studies require some in-person visits to our research lab, located at 42nd Ave and Clement St in San Francisco.
• Because this study includes an MRI, part of the screening process will be to ensure you don't have any metal in your body, you do not have head or neck tattoos, and you are comfortable inside the MRI scanner.
• 18-70 years with a confirmed COVID infection at least 3 months ago.
• Negative metal screen for MRI safety
• Normal (or corrected to normal) vision

Exclusion Criteria

• Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive symptoms)
• Loss of consciousness (LOC) greater than 30 minutes or any LOC with neurologic symptoms
• Major medical conditions (e.g., seizures disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology)
• Substance dependence, within the past year, or failed urine toxicology on the day of neuroimaging sessions
• Known claustrophobia
• Current pregnancy
• IQ estimate < 70

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID Control Group	cross-sectional MRI and EEG assessments (NO INTERVENTION)	Individuals (ages 18-70 years) who do not feel any different since recovering from initial COVID infection.
NeuroCOVID Group	cross-sectional MRI and EEG assessments (NO INTERVENTION)	Individuals (ages 18-70 years) who endorse a reported change in concentration, memory, feelings anxiety or depression since initial COVID infection.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Blood Biomarkers	1 month	We will correlate blood biomarkers of inflammation and NP test performance, thalamo-cortical connectivity, and measures of neural speed.
Number of Participants with MRI Functional Disconnectivity	1 month	We will compare thalamo-cortical connectivity in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Change of Neuropsychological Test Performance	1 month	We will compare NP test performance in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.
Number of Participants with EEG Latency & Amplitude	1 month	We will compare EEG-derived event related potential measures of neural speed in people with Covid-related worsening of attention, memory, anxiety, and/or depression to people who do not endorse worsening in those domains.

Trial Locations

Locations (1)

San Francisco Heathcare System; 🇺🇸 San Francisco, California, United States