Clinical trial NCT06208943: Neural and Cognitive Consequences of COVID-19 Survival
Official title: Neural and Cognitive Consequences of COVID-19 Survival
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID Long-Haul
COVID-19
COVID-19 Pandemic
Brain Fog
Memory Deficits
Concentration Ability Impaired
Fatigue
Keywords: EEG
fMRI
MRI
functional MRI
brain fog
long COVID
fatigue
difficulty concentrating
memory difficulty
Lead sponsor: San Francisco Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2024-01-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals 18-70 years old who were diagnosed with COVID-19 at least 3 months ago.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Neuropsychological Test Performance
timeFrame: 1 month
measure: Number of Participants with EEG Latency & Amplitude
timeFrame: 1 month
measure: Number of Participants with MRI Functional Disconnectivity
timeFrame: 1 month
measure: Number of Participants with Blood Biomarkers
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Heathcare System
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith M Ford, PhD
role: PRINCIPAL_INVESTIGATOR
References: