Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04564287
Status:
COMPLETED
Last Update Posted:
2023-12-19
First Post:
2020-09-24
Brief Title:
An Observational Study of Neurologic Function After COVID-19 Infection
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Observational Study of Neurologic Function After COVID -19 Infection
Status:
COMPLETED
Status Verified Date:
2023-12-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 Post-Acute Sequelae of SARS CoV-2 Infection PASC and many of these symptoms are neurologic neuro-PASC 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 SARS-CoV-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 Additionally by including a group of individuals who have fully recovered without residual neurological symptoms this study should be able to determine if there are abnormal results of study procedures in the absence of symptoms
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 Participants may return for an optional follow-up visit with a repeat of the study procedures done initially after at least 6 months from completion of their baseline study visit testing
Objectives
Primary Objective To investigate structural brain MRI in those with prior SARS-CoV-2 infection and persistent neurologic symptoms and in those with prior SARS-CoV-2 infection without persistent neurologic symptoms
Secondary objectiveTo investigate other components of neurologic function in those with prior SARS-CoV-2 infection and persistent neurologic symptoms and in those with prior SARS-CoV-2 infection and without 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 or neurochemical measures at rest or in response to the Valsalva maneuver or head-up tilting
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 Post-Acute Sequelae of SARS CoV-2 Infection PASC and many of these symptoms are neurologic neuro-PASC 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 SARS-CoV-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 Additionally by including a group of individuals who have fully recovered without residual neurological symptoms this study should be able to determine if there are abnormal results of study procedures in the absence of symptoms
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 Participants may return for an optional follow-up visit with a repeat of the study procedures done initially after at least 6 months from completion of their baseline study visit testing
Objectives
Primary Objective To investigate structural brain MRI in those with prior SARS-CoV-2 infection and persistent neurologic symptoms and in those with prior SARS-CoV-2 infection without persistent neurologic symptoms
Secondary objectiveTo investigate other components of neurologic function in those with prior SARS-CoV-2 infection and persistent neurologic symptoms and in those with prior SARS-CoV-2 infection and without 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 or neurochemical measures at rest or in response to the Valsalva maneuver or head-up tilting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000094-N | None | None | None |