Neural and Cognitive Consequences of COVID-19 Survival

NCT ID: NCT06208943

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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COVID Long-Haul COVID-19 COVID-19 Pandemic Brain Fog Memory Deficits Concentration Ability Impaired Fatigue

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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NeuroCOVID Group

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

cross-sectional MRI and EEG assessments (NO INTERVENTION)

Intervention Type OTHER

n/a there is no intervention in this observational study

COVID Control Group

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

cross-sectional MRI and EEG assessments (NO INTERVENTION)

Intervention Type OTHER

n/a there is no intervention in this observational study

Interventions

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cross-sectional MRI and EEG assessments (NO INTERVENTION)

n/a there is no intervention in this observational study

Intervention Type OTHER

Other Intervention Names

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cross-sectional MRI and EEG assessments

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Francisco Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Judith Ford

Staff Neuroscientist/Clinician Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith M Ford, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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San Francisco Heathcare System

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kaitlyn L Dal Bon, BA

Role: CONTACT

(415) 629-9514

Ken Lau, BS

Role: CONTACT

(415) 562-4334

Facility Contacts

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Kaitlyn L Dal Bon, BA

Role: primary

415-629-9514

Other Identifiers

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CX002322

Identifier Type: -

Identifier Source: org_study_id

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