PASC Post Acute Sequelae of COVID 19NCT07278388
Neural Mechanisms of Fatigue in Post-Acute Sequela of SARS-CoV-2
A study testing Physical Fatigue in people with PASC Post Acute Sequelae of COVID 19 and Fatigue, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
This proposal aims to understand the neurobiological mechanisms of fatigue in individuals with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). This knowledge will eventually provide candidate mechanisms to target with pharmacological intervention and inform rehabilitative care for those individuals suffering from… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PASC Post Acute Sequelae of COVID 19, Fatigue
- What is being tested?
- Physical Fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old.
- Have received a clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)/long COVID syndrome using the criteria specified by Thaweethai, et al., 2023 (JAMA). This symptom checklist provides a score based on the number and severity of symptoms. An individual with a score >12 is classified as having PASC.
- Currently experiencing Fatigue/Brain Fog as assessed with the Post-COVID symptom checklist and the PedsQL questionnaire.
Who cannot join
- Neurological disorders including, but not limited to, stroke, head injury, epilepsy, seizures, brain tumors, brain surgery, Parkinson's Disease, or any other neuromuscular disease (self-report).
- Diagnosed history of severe psychiatric diseases such as depression and schizophrenia (self-report).
- Congestive heart failure.
- Peripheral artery disease with claudication.
- Cancer.
- Pulmonary or renal failure.
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- Unstable angina.
- Uncontrolled hypertension (more than 190/110 mmHg).
- Severe aphasia.
- Orthopedic or pain conditions.
- Have had exposure to metal or metal implants, due to the hazardous effects of the magnetic field.
- If on immunomodulatory therapy, they must have been on that therapy for at least 6 months before the start of the study.
- Healthy age- and sex-matched controls for PASC - Exclusion criteria: Participants with a history of any of the following will be excluded from the study:
- Hospitalization due to SARS-CoV-2 infection.
- Neurological disorders including, but not limited to, stroke, head injury, epilepsy, seizures, brain tumors, brain surgery, Parkinson's Disease, or any other neuromuscular disease (self-report).
- Diagnosed history of severe psychiatric diseases such as depression and schizophrenia (self-report).
- Congestive heart failure.
- Peripheral artery disease with claudication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vikram Chib, PhD contact
United States1 site, 1 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21201
Anthony Gonzalez, 443-923-2716, gonzalezan@kennedykrieger.org
About this study
Official title: Motivated Decision-Making and Performance
This proposal aims to understand the neurobiological mechanisms of fatigue in individuals with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). This knowledge will eventually provide candidate mechanisms to target with pharmacological intervention and inform rehabilitative care for those individuals suffering from symptoms of fatigue in PASC.
- Conditions
- PASC Post Acute Sequelae of COVID 19, Fatigue
- Being tested
- Physical Fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical FatigueBehavioural
Participants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue.
| Study group | Role | What they receive |
|---|---|---|
| PASC Participants - Physical Fatigue Task | Experimental | Participants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue. Receives: Behavioral: Physical Fatigue |
| Control Participants - Physical Fatigue Task | Experimental | Participants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue. Receives: Behavioral: Physical Fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between PASC and HC - difference in mean Assessment Error
The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.
Measured: Baseline, during experimental protocol.
Comparing between PASC and HC - difference in BBB permeability
Collected from and MRI sequence designed to measure BBB permeability.
Measured: Baseline, during MRI acquisition.
Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state
We will examine an fMRI contrast, at the time of effort assessment, between HC and PASC groups. This contrast will examine percent signal change in brain activity.
Measured: Baseline, during experimental protocol.
The modulatory effect of BBB permeability on the relationship between Neural Activity and Effort Assessment
We will create a structural equation model that includes BBB permeability, fMRI activity, effort assessment behavior, and disease state (PASC/HC).
Measured: Baseline, during experimental protocol and MRI aquisition.
Comparing between PASC and HC - Difference in momentary subjective fatigue ratings
Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.
Measured: Baseline and during fatiguing exertions in the experimental protocol.
Comparing between PASC and HC - Difference in Mean Acceptance Rate of Risky Effort Options between rested/baseline and fatigue choices
Proportion of decisions in which inviduals choice to accept a risky effort opitions over a sure effort option.
Measured: Baseline and during fatiguing exertions in the experimental protocol.
Comparing between PASC and HC - Regions of the brain encoding a difference in effort cost between rested/baseline and fatigue choices
We will examine a contrast between chosen effort value pre versus post fatigue, between the HC and PASC groups. This contrast will examine percent signal change in brain activity.
Measured: Baseline and during fatiguing exertions in the experimental protocol.
The modulatory effect of BBB permeability on the relationship between Neural Activity and change effort-based decision-making
We will create a structural equation model that includes BBB permeability, fMRI activity, change in effort-based decision-making, and disease state (PASC/HC).
Measured: Baseline, fatigueing exertion, and during experimental protocol and MRI aquisition
Comparing between PASC and HC - Difference in mean assessment error as a function of time
The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.
Measured: Data collections at months 0, 3, 6, 12
Comparing between PASC and HC - Difference in momentary subjective fatigue ratings as a function of time
Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.
Measured: Data collections at months 0, 3, 6, 12
Comparing between PASC and HC - difference in BBB permeability as a function of time
Collected from and MRI sequence designed to measure BBB permeability.
Measured: Data collections at months 0, 3, 6, 12
Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state and time
We will examine a contrast, at the time of effort assessment, between HC and PASC groups, and use time as a covariate. This contrast will examine percent signal change in brain activity.
Measured: Data collections at months 0, 3, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start16 Jul 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PASC Post Acute Sequelae of COVID 19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikram Chib, PhD, Principal investigator, Johns Hopkins University; Kennedy Krieger Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278388
- Sponsor's protocol ID
- IRB00283000_1
- Other IDs
- R01NS140610
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivated Decision-Making and Performance
- ClinicalTrials.gov ID
- NCT07278388
- Acronym / sponsor ID
- IRB00283000_1
- Conditions
- PASC Post Acute Sequelae of COVID 19, Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Dec 2025 (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.
This proposal aims to understand the neurobiological mechanisms of fatigue in individuals with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). This knowledge will eventually provide candidate mechanisms to target with pharmacological intervention and inform rehabilitative care for those individuals suffering from symptoms of fatigue in PASC.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASC Participants - Physical Fatigue Task | Experimental | Behavioral: Physical FatigueParticipants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue. |
| Control Participants - Physical Fatigue Task | Experimental | Behavioral: Physical FatigueParticipants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75 years old.
- Have received a clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)/long COVID syndrome using the criteria specified by Thaweethai, et al., 2023 (JAMA). This symptom checklist provides a score based on the number and severity of symptoms. An individual with a score >12 is classified as having PASC.
- Currently experiencing Fatigue/Brain Fog as assessed with the Post-COVID symptom checklist and the PedsQL questionnaire.
Key exclusion criteria (18 listed)
- Neurological disorders including, but not limited to, stroke, head injury, epilepsy, seizures, brain tumors, brain surgery, Parkinson's Disease, or any other neuromuscular disease (self-report).
- Diagnosed history of severe psychiatric diseases such as depression and schizophrenia (self-report).
- Congestive heart failure.
- Peripheral artery disease with claudication.
- Cancer.
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 |
|---|---|---|
| Physical FatigueParticipants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue. | Behavioural | Control Participants - Physical Fatigue Task, PASC Participants - Physical Fatigue Task |
Primary outcome
Comparison between PASC and HC - difference in mean Assessment Error
Time frame: Baseline, during experimental protocol.
The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.
Comparing between PASC and HC - difference in BBB permeability
Time frame: Baseline, during MRI acquisition.
Collected from and MRI sequence designed to measure BBB permeability.
Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state
Time frame: Baseline, during experimental protocol.
We will examine an fMRI contrast, at the time of effort assessment, between HC and PASC groups. This contrast will examine percent signal change in brain activity.
The modulatory effect of BBB permeability on the relationship between Neural Activity and Effort Assessment
Time frame: Baseline, during experimental protocol and MRI aquisition.
We will create a structural equation model that includes BBB permeability, fMRI activity, effort assessment behavior, and disease state (PASC/HC).
Comparing between PASC and HC - Difference in momentary subjective fatigue ratings
Time frame: Baseline and during fatiguing exertions in the experimental protocol.
Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.
Comparing between PASC and HC - Difference in Mean Acceptance Rate of Risky Effort Options between rested/baseline and fatigue choices
Time frame: Baseline and during fatiguing exertions in the experimental protocol.
Proportion of decisions in which inviduals choice to accept a risky effort opitions over a sure effort option.
Comparing between PASC and HC - Regions of the brain encoding a difference in effort cost between rested/baseline and fatigue choices
Time frame: Baseline and during fatiguing exertions in the experimental protocol.
We will examine a contrast between chosen effort value pre versus post fatigue, between the HC and PASC groups. This contrast will examine percent signal change in brain activity.
The modulatory effect of BBB permeability on the relationship between Neural Activity and change effort-based decision-making
Time frame: Baseline, fatigueing exertion, and during experimental protocol and MRI aquisition
We will create a structural equation model that includes BBB permeability, fMRI activity, change in effort-based decision-making, and disease state (PASC/HC).
Comparing between PASC and HC - Difference in mean assessment error as a function of time
Time frame: Data collections at months 0, 3, 6, 12
The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.
Comparing between PASC and HC - Difference in momentary subjective fatigue ratings as a function of time
Time frame: Data collections at months 0, 3, 6, 12
Measures of subjective fatigue will be collected on self report scale that ranges from 'not fatigued at all' to 'very fatigued'.
Comparing between PASC and HC - difference in BBB permeability as a function of time
Time frame: Data collections at months 0, 3, 6, 12
Collected from and MRI sequence designed to measure BBB permeability.
Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state and time
Time frame: Data collections at months 0, 3, 6, 12
We will examine a contrast, at the time of effort assessment, between HC and PASC groups, and use time as a covariate. This contrast will examine percent signal change in brain activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection
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.
Vikram Chib, PhD contact
Vikram Chib, PhD principal investigator
Johns Hopkins University; Kennedy Krieger Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Fatigue in people with PASC Post Acute Sequelae of COVID 19 and Fatigue, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. 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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 12 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Gonzalez (443-923-2716, gonzalezan@kennedykrieger.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between PASC and HC - difference in mean Assessment Error (time frame: Baseline, during experimental protocol.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.