Infectious Metabolic EncephalopathyNCT05746624
Procedural Motor Memory in Long COVID-19
An observational study of Infectious Metabolic Encephalopathy and Ischemic Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infectious Metabolic Encephalopathy, Ischemic Stroke, Seizure
- What is being tested?
- keypresses
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 17 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with long COVID were recruited from NIH protocol 000089 Post- Coronavirus Disease 19 Convalescence at the National Institutes of Health . These subjects were matched by age and sex to healthy volunteers recruited online using the Prolific.co crowdsourcing platform. All participants were able to review and understand acknowledgment of participation, age 18 at time of enrollment, English-speaking, able to type without discomfort, and with access to a physical keyboard. Healthy volunteers additionally reported not having active fever or residual symptoms following Covid infection.
Who may be able to join
- 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.
Show all 20Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
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.
Read more
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....
Read the 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.
- Conditions
- Infectious Metabolic Encephalopathy, Ischemic Stroke, Seizure, Viral Encephalitis, Small and Large Vessel
- Being tested
- keypresses
- Keywords
- Corona Virus
- Medical subject headings
- Ischemic Stroke, Seizures, Encephalitis, Viral, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keypressesBehavioural
benign behavioral intervention-- keypresses
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Long COVID left handed | Long COVID left handed Receives: Behavioral: keypresses | |
| Arm 1 Long COVID right handed | Long COVID right handed Receives: Behavioral: keypresses | |
| Arm 2 Healthy Controls left handed | healthy left handed Receives: Behavioral: keypresses | |
| Arm 2 Healthy Controls right handed | healthy right handed Receives: Behavioral: keypresses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: anticipated to complete data analysis by December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start15 Nov 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious Metabolic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Leonardo G Cohen, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746624
- Sponsor's protocol ID
- 10000466
- Other IDs
- 000466-N
- Status last verified
- 27 Mar 2025
- First submitted
- 18 Feb 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hayward W, Buch ER, Norato G, Iwane F, Dash D, Salamanca-Giron RF, Bartrum E, Walitt B, Nath A, Cohen LG. Procedural Motor Memory Deficits in Patients With Long-COVID. Neurology. 2024 Feb 13;102(3):e208073. doi: 10.1212/WNL.0000000000208073. Epub 2024 Jan 18.
PubMed 38237090
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Motor Memory in Long COVID-19
- ClinicalTrials.gov ID
- NCT05746624
- Acronym / sponsor ID
- 10000466
- Conditions
- Infectious Metabolic Encephalopathy, Ischemic Stroke, Seizure, Viral Encephalitis, Small and Large Vessel
- Keywords
- Corona Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Long COVID left handed | – | Behavioral: keypressesLong COVID left handed |
| Arm 1 Long COVID right handed | – | Behavioral: keypressesLong COVID right handed |
| Arm 2 Healthy Controls left handed | – | Behavioral: keypresseshealthy left handed |
| Arm 2 Healthy Controls right handed | – | Behavioral: keypresseshealthy right handed |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with long COVID were recruited from NIH protocol 000089 Post- Coronavirus Disease 19 Convalescence at the National Institutes of Health . These subjects were matched by age and sex to healthy volunteers recruited online using the Prolific.co crowdsourcing platform. All participants were able to review and understand acknowledgment of participation, age 18 at time of enrollment, English-speaking, able to type without discomfort, and with access to a physical keyboard. Healthy volunteers additionally reported not having active fever or residual symptoms following Covid infection.
Key inclusion criteria (20 listed)
- 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?
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| keypressesbenign behavioral intervention-- keypresses | Behavioural | Arm 1 Long COVID left handed, Arm 1 Long COVID right handed, Arm 2 Healthy Controls left handed, Arm 2 Healthy Controls right handed |
Primary outcome
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 ...
Time frame: anticipated to complete data analysis by December 2023
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 38237090Hayward W, Buch ER, Norato G, Iwane F, Dash D, Salamanca-Giron RF, Bartrum E, Walitt B, Nath A, Cohen LG. Procedural Motor Memory Deficits in Patients With Long-COVID. Neurology. 2024 Feb 13;102(3):e208073. doi: 10.1212/WNL.0000000000208073. Epub 2024 Jan 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo G Cohen, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Metabolic Encephalopathy and Ischemic Stroke, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 ... (time frame: anticipated to complete data analysis by December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.