An Observational Study of Neurologic Function After COVID-19 Infection

NCT04564287 | Completed

• 2 other identifiers: 10000094000094-N
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Background: COVID-19 is an infection caused by a coronavirus. It can affect different parts of the body. For most people, it causes fevers or trouble breathing. Some people can have symptoms long after they recover. Researchers want to learn if there are signs of changes in the nervous system that may be related to COVID-19. Objective: To test the nervous system (the brain and nerves) in people who have had COVID-19 yet still have certain symptoms even after recovering. Eligibility: People age 18 and older who had COVID-19 and still have neurologic symptoms after they recovered from the initial infection. Design: Participants will be screened with a medical record review. Participants will have a neurological exam. They will complete pen-and-paper tests of their memory and thinking. They will complete a smell test with 'scratch-and-sniff' booklets. They will give blood samples. Participants will have magnetic resonance imaging (MRI) of the brain. Soft padding or a coil will be placed around their head. They will lie on a table that slides in and out of the MRI scanner. They will get a contrast dye through an intravenous (IV) catheter. Participants blood pressure, blood flow, skin temperature, sweating, and breathing will be monitored. Participants will have an electrocardiogram to measure heart function. Participants will blow into a mouthpiece for several seconds. Participants will lie on a table that has a motor. The motor tilts the table. Participants will have blood drawn through an IV as the table tilts. Participants will have a lumbar puncture. A small needle will be inserted into the spinal canal to obtain fluid. Participants may repeat some tests 8 weeks to 1 year later.

Conditions

COVID-19

Keywords

Neurological; COVID-19; Coronavirus; Autonomic; Brain; Natural History

Outcome Measures

Primary Outcomes (1)

• MRI brain

  The number and character of brain MRI abnormalities on a dedicated research MRI protocol optimized to detect Covid-19-associated disease.

  NIH Clinical Center Visit

Secondary Outcomes (2)

• Neurological Examination

  NIH Clinical Center Visit

• Autonomic Testing

  NIH Clinical Center Visit

Study Arms (2)

Fully Recovered Individuals

Individuals with history of Covid-19 infection who have fully recovered without residual neurological symptoms

Patients with neuro-PASC

Patients with history of Covid-19 infection and persistent neurological symptoms (Post-Acute Sequelae of SARS CoV-2 Infection, neuro-PASC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• In order to be eligible to participate in the PASC cohort, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged at least 18 years at the time of enrollment
• Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
• Do you have ongoing issues with being lightheaded or dizzy and if so, are these issues made worse when you sit or stand up
• quickly?
• Do you have ongoing issues with gait instability, problems with vision, speech, swallowing?
• Do you have ongoing issues with sensation or strength in your face/arms/legs?
• Ability of subject to understand and the willingness to sign a written informed consent document.
• In order to be eligible to participate in the Fully Recovered cohort, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged at least 18 years at the time of enrollment
• Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
• A self-reported illness narrative of recovery to prior health after a SARS/CoV2 infection, without residual fatigue, brain fog, orthostatic intolerance, or exercise intolerance.
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Presence of a contraindication to research MRI with gadolinium, including contraindicated metal in the body, prior allergic reaction to gadolinium, eGFR \<45 mmol/L, pregnancy or lactation, or claustrophobia that is unable to be adequately treated with a low oral dose of a benzodiazepine.
• Contraindication to a research lumbar puncture, including use of anticoagulant medication, platelets \< 50,000/microL, PT or PTT \>1.5 x ULN for the NIH Clinical Center, or otherwise inability to complete the procedure.
• Contraindication to autonomic testing, including refractory ventricular arrhythmias or symptomatic coronary artery disease.
• A condition prior to the diagnosis of COVID-19 infection that would significantly confound interpretation of the research tests (e.g., prior diagnosis of postural orthostatic tachycardia syndrome), as determined by the study investigators.
• Fever or respiratory symptoms in the last seven days.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19; Neurologic Manifestations; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Avindra Nath, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 25, 2020
• Study Start: October 28, 2020
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)