Neural and Cognitive Consequences of COVID-19 Survival

NCT06208943 | Recruiting

• 1 other identifier: CX002322
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Change of Neuropsychological Test Performance

  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.

  1 month

• Number of Participants with EEG Latency & Amplitude

  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.

  1 month

• Number of Participants with MRI Functional Disconnectivity

  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.

  1 month

• Number of Participants with Blood Biomarkers

  We will correlate blood biomarkers of inflammation and NP test performance, thalamo-cortical connectivity, and measures of neural speed.

  1 month

Study Arms (2)

NeuroCOVID Group

Individuals (ages 18-70 years) who endorse a reported change in concentration, memory, feelings anxiety or depression since initial COVID infection.

Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)

COVID Control Group

Individuals (ages 18-70 years) who do not feel any different since recovering from initial COVID infection.

Other: cross-sectional MRI and EEG assessments (NO INTERVENTION)

Interventions

cross-sectional MRI and EEG assessments (NO INTERVENTION) OTHER

n/a there is no intervention in this observational study

Also known as: cross-sectional MRI and EEG assessments

COVID Control Group; NeuroCOVID Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals 18-70 years old who were diagnosed with COVID-19 at least 3 months ago.

You may qualify if:

• 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.
• years with a confirmed COVID infection at least 3 months ago.
• Negative metal screen for MRI safety
• Normal (or corrected to normal) vision

You may not qualify if:

• 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

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead

Study Sites (1)

San Francisco Heathcare System

San Francisco, California, 94121, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood draw

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Mental Fatigue; Memory Disorders; Fatigue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Judith M Ford, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlyn L Dal Bon, BA

CONTACT

(415) 629-9514; kaitlyn.dalbon@ucsf.edu

Ken Lau, BS

CONTACT

(415) 562-4334; ken.lau@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Neuroscientist/Clinician Investigator

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 17, 2024
• Study Start: October 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)