Neural and Cognitive Consequences of COVID-19 Survival

COVID-19 Clinical Trial

Official title:

Neural and Cognitive Consequences of COVID-19 Survival

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208943
• Other study ID #: CX002322
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: San Francisco Veterans Affairs Medical Center
• Contact: Kaitlyn L Dal Bon, BA
• Phone: (415) 629-9514
• Email: kaitlyn.dalbon[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Concentration Ability Impaired
• COVID-19
• COVID-19 Pandemic
• Fatigue
• Memory Deficits
• Memory Disorders
• Mental Fatigue

Intervention

Other:
• cross-sectional MRI and EEG assessments (NO INTERVENTION)
n/a there is no intervention in this observational study

Locations

Country	Name	City	State
United States	San Francisco Heathcare System	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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