An Observational Study of Neurologic Function After COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04564287|
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : August 4, 2021
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.
To test the nervous system (the brain and nerves) in people who have had COVID-19 yet still have certain symptoms even after recovering.
People age 18 and older who had COVID-19 and still have neurologic symptoms after they recovered from the initial infection.
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.
|Condition or disease|
Study Description: This study will characterize ongoing neurologic abnormalities in those who recovered from acute COVID-19 infection yet have persistent neurologic symptoms. Despite clinical recovery from the acute infection, some individuals continue to experience ongoing symptoms, at times several months after recovery, and many of these symptoms are neurologic. The NIH Clinical Center provides the breadth of expertise and resources to best investigate this patient group. This study will collect a broad array of specialized neurologic testing in this group who, despite recovering from the acute SARSCoV-2 infection, continue to experience neurological symptoms. It is hypothesized that this group will have abnormalities on neurologic testing that may identify discrete phenotypes of COVID-19 sequelae.
Pre-screening for this study will be done under the study, 'Post-Coronavirus Disease 19 Syndrome at the National Institutes of Health.' Potentially eligible participants will be identified under the screening arm of that study and will be referred to the study team. If deemed eligible for this study based on a review of available records and a telephone discussion with the potential participant, participants may enroll. Enrollment will include a visit to the NIH Clinical Center for informed consent and completion of the study procedures. We anticipate that the baseline study procedures will take approximately 2-3 outpatient visits to complete or the participant may be admitted as an inpatient. If there are abnormalities noted on the baseline study procedures, participants may return for a repeat of some study procedures within 12 months from completion of their baseline study visit.
Primary Objective: To investigate structural abnormalities by brain MRI in those with prior SARS-CoV-2 infection and persistent neurologic symptoms.
Secondary objective: To investigate other components of neurologic function in those with prior SARS-CoV-2 infection and persistent neurologic symptoms.
Endpoints: Primary endpoint: The number and character of brain MRI abnormalities on a dedicated research MRI protocol optimized to detect COVID-19-associated disease.
Secondary endpoints: 1. Neurologic examination: The number and character of abnormalities associated with both central and peripheral nervous system disease. 2. Autonomic testing: The number and character of test results indicating autonomic nervous system or catecholaminergic dysfunctions as evidenced by abnormal physiological and neurochemical measures at rest or in responses to the Valsalva maneuver or head-up tilting.
Study Population: This study will enroll 50 participants.
Description of Sites/Facilities Enrolling Participants: The NIH Clinical Center will be the site of all research studies done under this protocol.
Study Duration: We anticipate that this study will begin enrollment September 2020 and will complete data analysis by December 2022.
Participant Duration: Participants will complete all required study procedures within an approximately two-week time frame. Participants may return for optional follow up with a repeat of some study procedures and those participants will complete the study at that point.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||An Observational Study of Neurologic Function After COVID-19 Infection|
|Actual Study Start Date :||October 28, 2020|
|Estimated Primary Completion Date :||October 30, 2022|
|Estimated Study Completion Date :||October 31, 2022|
Patients with history of Covid-19 infection and persistent neurological symptoms
- MRI brain abnormalities [ Time Frame: at NIH Clinical Center Visit ]The number and character of brain MRI abnormalities on a dedicated research MRI protocol optimized to detect Covid-19-associated disease.
- Neurological Examination [ Time Frame: At NIH Clinical Center Visit ]Neurologic examination: The number and character of abnormalities associated with both central and peripheral nervous system disease.
- Autonomic Testing [ Time Frame: At NIH Clinical Center Visit ]Autonomic testing: The number and character of test results indicating autonomic nervous system disease as evidenced by abnormal heart rate and blood pressure responses during tilt table testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564287
|Contact: Janna Gelsomino, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Avindra Nath, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|