CClinicalTrials.gg
RecruitingNCT06208943Updated Apr 12, 2024

Neural and Cognitive Consequences of COVID-19 Survival

An observational study in COVID Long-Haul, COVID-19 and COVID-19 Pandemic, sponsored by San Francisco Veterans Affairs Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by San Francisco Veterans Affairs Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Othercross-sectional MRI and EEG assessments (NO INTERVENTION)

    n/a there is no intervention in this observational study

    Also known as: cross-sectional MRI and EEG assessments

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

  2. 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.

    Time frame: 1 month

  3. 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.

    Time frame: 1 month

  4. 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.

    Time frame: 1 month

06

Study locations

1 of 1 sites recruiting
  • San Francisco Heathcare System
    San Francisco, California 94121, United States
    • Kaitlyn L Dal Bon, BA · Contact · kaitlyn.dalbon@ucsf.edu · 415-629-9514
    • Judith M Ford, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Not part of currently approved protocol or original agreement with sponsor.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06208943
Lead sponsor
San Francisco Veterans Affairs Medical Center
Responsible party
Judith Ford (Staff Neuroscientist/Clinician Investigator, San Francisco Veterans Affairs Medical Center) — Principal investigator
First posted
Jan 17, 2024
Start date
Oct 1, 2021
Primary completion
Jun 1, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Apr 12, 2024

Study contacts

Kaitlyn L Dal Bon, BA
Contact
kaitlyn.dalbon@ucsf.edu
(415) 629-9514
Ken Lau, BS
Contact
ken.lau@ucsf.edu
(415) 562-4334
Judith M Ford, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion