NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

An Observational Study of Neurologic Function after COVID-19 Infection

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000094-N

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Neurological;
COVID-19;
Corona Virus;
Autonomic;
Brain

Recruitment Keyword(s)

None

Condition(s)

COVID-19

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study

2. Male or female, aged at least 18 years at the time of enrollment

3. Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health

4. Positive COVID-19 test result at least six weeks prior to enrollment and exhibiting persistent neurologic symptoms evidenced by a positive response to at least one of the following:

a. 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?

b. Do you have ongoing issues with gait instability, problems with vision, speech, swallowing?

c. Do you have ongoing issues with sensation or strength in your face/arms/legs?

5. Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Presence of a contraindication to research MRI brain 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 dose oral benzodiazepine.

2. 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.

3. Contraindication to autonomic testing, including refractory ventricular arrhythmias or symptomatic coronary artery disease.

4. 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 Hypotension Syndrome), as determined by the study investigators.

5. Fever or respiratory symptoms in the last seven days.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Avindra Nath, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Janna Gelsomino, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5653
10 Center Drive
Bethesda, Maryland 20892
(301) 435-5166
janna.gelsomino@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04564287

--Back to Top--