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Procedural Motor Memory in Long COVID-19

Primary Purpose

Infectious Metabolic Encephalopathy, Ischemic Stroke, Seizure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
keypresses
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infectious Metabolic Encephalopathy focused on measuring Corona Virus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: In order to be eligible to participate in this study, patient volunteers must meet all of the following criteria: Ability of subject to understand and the willingness to review an informed consent Aged at least 18 years at the time of enrollment, and no older than 90 years of age. Identity of dominant hand Question: Which hand would you choose to hold the pen to write a formal letter? Note: no specific answer is required for inclusion, but it is required for the next question. English-Speaking: Ability to type without discomfort using non-dominant hand Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health in the post-COVID convalescence arm (i.e. reports having started recovery from an acute COVID- 19 infection within past six month and is able to provide documentation of a positive COVID-19 PCR or antibody test) In order to be eligible to participate in this study, healthy volunteers must meet all of the following criteria: Ability of subject to understand and the willingness to review an acknowledgement of participation agreement Aged at least 18 years at the time of enrollment, and no older than 90 years of age English-speaking Ability to identify dominant hand Question: Which hand would you choose to hold the pen to write a formal letter? Note: no specific answer is required for inclusion, but it is required for the next question. Ability to type without discomfort using non-dominant hand Deny active infection with COVID-19, or ongoing symptoms following COVID-19 infection Ability to use an internet-connected laptop or desktop computer in a private setting located in the continental U.S. to complete the study task. This protocol can enroll NIH Employees/staff, including NINDS employees/staff. Staff members from our section and their immediate family members are excluded from participation. EXCLUSION CRITERIA: Patient group: A patient who meets any of the following criteria will be excluded from participation in this study: A condition prior to the diagnosis of COVID-19 infection that would significantly confound interpretation of the behavioral task, as determined by the screening clinician (e.g., prior diagnosis of a neurologic condition such as large stroke, Alzheimer s disease or Parkinson s disease, or severe psychiatric condition). Staff from our section, and their immediate family members Healthy Volunteer group: A person who meets any of the following criteria will be excluded from participation in this study: A condition that would significantly confound interpretation of the research tests as determined by the screening clinician (e.g., prior diagnosis of a neurologic condition such as large stroke, Alzheimer s disease or Parkinson s disease, or severe psychiatric condition) Fever, respiratory symptoms or diagnosis of COVID-19 in the last 14 days. History of COVID-19 with residual neurologic symptoms following diagnosis that did not resolve within 14 days of disease onset. Previous participation in this study (platform filter).

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1 Long COVID left handed

Arm 1 Long COVID right handed

Arm 2 Healthy Controls left handed

Arm 2 Healthy Controls right handed

Arm Description

Long COVID left handed

Long COVID right handed

healthy left handed

healthy right handed

Outcomes

Primary Outcome Measures

To investigate differences in procedural memory formation and consolidation during a keyboard typing task between o patients withpersistent symptoms following COVID- 19 infection ( long COVID )and matched controls who deny symptoms of ...
Early procedural motor memory learning will be measuredby the difference in keypress speed between the first training trial and last correct training trial of the Day 1 typing task.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2023
Last Updated
August 2, 2023
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05746624
Brief Title
Procedural Motor Memory in Long COVID-19
Official Title
Procedural Motor Memory in Long COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
April 5, 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Most people who get COVID-19 seem to recover with no long-term effects. However, some people who recover from acute COVID-19 infections report lingering symptoms. This is called long COVID. Many people with long COVID report symptoms related to the nervous system; these can include problems with fatigue, speech, and memory. Objective: To test motor memory in people with long COVID, compared to healthy volunteers. Eligibility: People aged 18 to 90 years who are also enrolled in study protocol 000089. Healthy adults are also needed. Design: Participants will be screened by telephone. They will confirm they are able to type without discomfort using their nondominant hand. They will confirm they have access to a computer connected to the internet. All study tasks will be done online. Participants will complete 2 tasks in 2 days. Participants will be sent a link to a website. The website will give them instructions. They will place the fingers of their nondominant hand over 4 numbers on the keyboard and type a sequence (eg, 4-1-3-2-4). They will type this sequence as often as they can in 10 seconds. Then they will rest for 10 seconds before repeating the task. They will repeat this pattern for 15 minutes. After they finish the typing task, participants will take a 10-minute questionnaire. They will answer questions about their experiences with COVID-19 and memory issues; they will say which hand they use for tasks such as brushing their teeth or throwing a ball. Participants will get a notice to repeat the typing task 22 hours after they finish the first one. They should complete the second task within 28 hours....
Detailed Description
This study will objectively test procedural motor memory in a group of people with ongoing symptoms following recovery from acute COVID-19 infection. Primary Objective: We will use a keyboard typing task to investigate procedural memory formation (primary endpoint measure) in the context of COVID-19 infection. We have two primary comparisons using the same outcome measure To compare procedural memory formation between patients with persistent symptoms following COVID-19 infection ( long COVID ) and matched controls who deny symptoms of long COVID (as reported in self-report questionnaires). To compare procedural memory formation between long COVID patients with memory complaints and long COVID patients without memory complaints. Secondary objectives: Micro-online gains, micro-offline gains, and long-term consolidation (all secondary measures) will be investigated between patients with long COVID and matched controls. between long COVID patients with memory complaints and long COVID patients without memory complaints Exploratory objectives: To compare primary and secondary outcome measures between long COVID patients and healthy controls who report prior COVID-19 infection but are not suffering long COVID symptoms Primary endpoint measure: Early procedural memory formation, as measured by the difference in tapping speed (keypresses/second) between the first and last correct training trial of early learning (first 11 trials) in a keyboard task. Secondary endpoint measures: Micro-online learning. Performance improvements within training trials Micro-offline learning (rapid consolidation). Performance improvements during rest intervals interspersed with training periods. Longer-term consolidation (24 hours). Performance improvements between the last training trial of Day 1 and the testing trial of Day 2. We hypothesize that early procedural motor memory learning will be reduced in long COVID patients as compared to healthy controls (primary hypothesis). Seondarily, we hypothesize that micro-online learning, micro-offline learning (rapid consolidation), and longer term consolidation (24 hours) will be also reduced in long COVID patients as compared to controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Metabolic Encephalopathy, Ischemic Stroke, Seizure, Viral Encephalitis, Small and Large Vessel
Keywords
Corona Virus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Long COVID left handed
Arm Type
Experimental
Arm Description
Long COVID left handed
Arm Title
Arm 1 Long COVID right handed
Arm Type
Experimental
Arm Description
Long COVID right handed
Arm Title
Arm 2 Healthy Controls left handed
Arm Type
Experimental
Arm Description
healthy left handed
Arm Title
Arm 2 Healthy Controls right handed
Arm Type
Experimental
Arm Description
healthy right handed
Intervention Type
Behavioral
Intervention Name(s)
keypresses
Intervention Description
benign behavioral intervention-- keypresses
Primary Outcome Measure Information:
Title
To investigate differences in procedural memory formation and consolidation during a keyboard typing task between o patients withpersistent symptoms following COVID- 19 infection ( long COVID )and matched controls who deny symptoms of ...
Description
Early procedural motor memory learning will be measuredby the difference in keypress speed between the first training trial and last correct training trial of the Day 1 typing task.
Time Frame
anticipated to complete data analysis by December 2023

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: In order to be eligible to participate in this study, patient volunteers must meet all of the following criteria: Ability of subject to understand and the willingness to review an informed consent Aged at least 18 years at the time of enrollment, and no older than 90 years of age. Identity of dominant hand Question: Which hand would you choose to hold the pen to write a formal letter? Note: no specific answer is required for inclusion, but it is required for the next question. English-Speaking: Ability to type without discomfort using non-dominant hand Enrolled in the screening phase of Protocol 000089 Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health in the post-COVID convalescence arm (i.e. reports having started recovery from an acute COVID- 19 infection within past six month and is able to provide documentation of a positive COVID-19 PCR or antibody test) In order to be eligible to participate in this study, healthy volunteers must meet all of the following criteria: Ability of subject to understand and the willingness to review an acknowledgement of participation agreement Aged at least 18 years at the time of enrollment, and no older than 90 years of age English-speaking Ability to identify dominant hand Question: Which hand would you choose to hold the pen to write a formal letter? Note: no specific answer is required for inclusion, but it is required for the next question. Ability to type without discomfort using non-dominant hand Deny active infection with COVID-19, or ongoing symptoms following COVID-19 infection Ability to use an internet-connected laptop or desktop computer in a private setting located in the continental U.S. to complete the study task. This protocol can enroll NIH Employees/staff, including NINDS employees/staff. Staff members from our section and their immediate family members are excluded from participation. EXCLUSION CRITERIA: Patient group: A patient who meets any of the following criteria will be excluded from participation in this study: A condition prior to the diagnosis of COVID-19 infection that would significantly confound interpretation of the behavioral task, as determined by the screening clinician (e.g., prior diagnosis of a neurologic condition such as large stroke, Alzheimer s disease or Parkinson s disease, or severe psychiatric condition). Staff from our section, and their immediate family members Healthy Volunteer group: A person who meets any of the following criteria will be excluded from participation in this study: A condition that would significantly confound interpretation of the research tests as determined by the screening clinician (e.g., prior diagnosis of a neurologic condition such as large stroke, Alzheimer s disease or Parkinson s disease, or severe psychiatric condition) Fever, respiratory symptoms or diagnosis of COVID-19 in the last 14 days. History of COVID-19 with residual neurologic symptoms following diagnosis that did not resolve within 14 days of disease onset. Previous participation in this study (platform filter).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret K Hayward, C.R.N.P.
Phone
(301) 451-1335
Email
mimi.hayward@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo G Cohen, M.D.
Phone
(301) 496-9782
Email
cohenl1@mail.nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo G Cohen, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Hayward, M.S.N.
Phone
301-451-1335
Email
mimi.hayward@nih.gov

12. IPD Sharing Statement

Learn more about this trial

Procedural Motor Memory in Long COVID-19

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