Recruiting

Observational Study

Sponsor:

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Code:

NCT07278388

Conditions

PASC Post Acute Sequelae of COVID 19

Fatigue

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Physical Fatigue

Study Details

Brief 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 symptoms of fatigue in PASC.

Conditions

PASC Post Acute Sequelae of COVID 19

Fatigue

Study ID

NCT07278388

Start date

Jul 16, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: PASC Participants - Physical Fatigue Task

Participants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue.

experimental: Control Participants - Physical Fatigue Task

Participants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue.

Interventions

Physical Fatigue

Participants will perform a physically demanding task (grip force exertion task) repeatedly to induce physical fatigue.

Primary outcome measure

  • Comparison between PASC and HC - difference in mean Assessment Error [ Time Frame: Baseline, during experimental protocol. ]
  • Comparing between PASC and HC - difference in BBB permeability [ Time Frame: 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 [ Time Frame: Baseline, during experimental protocol. ]
  • The modulatory effect of BBB permeability on the relationship between Neural Activity and Effort Assessment [ Time Frame: Baseline, during experimental protocol and MRI aquisition. ]
  • Comparing between PASC and HC - Difference in momentary subjective fatigue ratings [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Data collections at months 0, 3, 6, 12 ]
  • 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 ]
  • Comparing between PASC and HC - difference in BBB permeability as a function of time [ Time Frame: 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 [ Time Frame: Data collections at months 0, 3, 6, 12 ]

Central Contacts and Locations

Central contacts

Anthony Gonzalez

443-923-2716gonzalezan@kennedykrieger.org

Locations

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Anthony Gonzalez

443-923-2716gonzalezan@kennedykrieger.org

More Information

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2025-12-12.