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Understanding Fatigue in Long COVID (PASC)

This study is looking for volunteers aged 18 to 75 who have been diagnosed with Post-Acute Sequelae of SARS-CoV-2 (PASC), also known as Long COVID, and experience fatigue. The goal is to understand the brain mechanisms behind fatigue in PASC. Participants will perform a physically demanding task, like repeatedly squeezing a handgrip, to induce fatigue. Researchers will then compare brain activity and other measures between people with PASC and healthy individuals. The study hopes to identify specific brain changes related to fatigue in PASC, which could lead to new treatments and better care. The study aims to enroll 200 participants, but its current recruitment status is unclear.

Study design
This is an interventional study aiming to enroll 200 participants. It compares individuals with PASC to healthy controls.
What's involved
Participants will perform a physically demanding task (grip force exertion) and undergo MRI scans at baseline and during the experimental protocol.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07278388

Neural Mechanisms of Fatigue in Post-Acute Sequela of SARS-CoV-2

Recruiting
NAAges 18–75InterventionalBasic science
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
~200 participants
Updated 2025-12-12 on ClinicalTrials.gov
What's tested:Physical Fatigue

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison between PASC and HC - difference in mean Assessment Error
Measured over Baseline, during experimental protocol.
+11 more outcomes measured

Conditions

PASC Post Acute Sequelae of COVID 19
Fatigue

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FatiguePost-Acute Sequelae of COVID-19

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Vikram Chib, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University; Kennedy Krieger Institute

Who to contact

Anthony Gonzalez
[email protected]
443-923-2716
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.
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.

What this trial measures

  • Comparison between PASC and HC - difference in mean Assessment ErrorBaseline, 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 permeabilityBaseline, 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 stateBaseline, 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 AssessmentBaseline, 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 ratingsBaseline 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 choicesBaseline 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 choicesBaseline 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-makingBaseline, 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 timeData 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 timeData 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 timeData 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 timeData 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.