Recruiting

Observational Study

Sponsor:

San Francisco Veterans Affairs Medical Center

Code:

NCT06208943

Conditions

COVID Long-Haul

COVID-19

COVID-19 Pandemic

Brain Fog

Memory Deficits

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

cross-sectional MRI and EEG assessments (NO INTERVENTION)

Study Details

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

Study ID

NCT06208943

Start date

Oct 1, 2021

Status verified date

Apr, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

NeuroCOVID Group

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

COVID Control Group

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

Interventions

cross-sectional MRI and EEG assessments (NO INTERVENTION)

n/a there is no intervention in this observational study

Primary outcome measure

  • Change of Neuropsychological Test Performance [ Time Frame: 1 month ]
  • Number of Participants with EEG Latency & Amplitude [ Time Frame: 1 month ]
  • Number of Participants with MRI Functional Disconnectivity [ Time Frame: 1 month ]
  • Number of Participants with Blood Biomarkers [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Kaitlyn L Dal Bon, BA

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

Ken Lau, BS

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

Locations

San Francisco Heathcare System

Recruiting

San Francisco, California, United States, 94121

Contacts

Kaitlyn L Dal Bon, BA

415-629-9514kaitlyn.dalbon@ucsf.edu

Principal Investigator:

Judith M Ford, PhD

More Information

Sponsor

San Francisco Veterans Affairs Medical Center

Last update posted

Apr 12, 2024

Last verified

Apr, 2024

Keywords

  • EEG
  • fMRI
  • MRI
  • functional MRI
  • brain fog
  • long COVID
  • fatigue
  • difficulty concentrating
  • memory difficulty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Francisco Veterans Affairs Medical Center on 2024-04-12.