What in the brain causes fatigue after COVID-19
Motivated Decision-Making and Performance
NA · Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · NCT07278388
This project will see what's happening in the brains of adults with long COVID who have ongoing fatigue or brain fog to find targets for treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07278388 on ClinicalTrials.gov |
What this trial studies
The trial will enroll adults aged 18–75 who meet the Thaweethai criteria for PASC (score >12) and who currently report fatigue or brain fog using standard symptom checklists and the PedsQL. Participants will undergo tests that induce or probe physical fatigue alongside neurobiological measurements to characterize neural responses associated with their symptoms. Data will be used to identify candidate brain systems and pathways that could be targeted by drugs or rehabilitative approaches. The work is being conducted at the Kennedy Krieger Institute in collaboration with NINDS.
Who should consider this trial
Good fit: Adults 18–75 with a clinician-confirmed PASC diagnosis (Thaweethai checklist score >12) who currently report fatigue or brain fog are the intended participants.
Not a fit: People without PASC-related fatigue, or those with major neurological illness, severe psychiatric disorders, or serious cardiac/pulmonary/renal disease are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could point to specific brain systems to target with medications or rehabilitation to reduce fatigue in long COVID.
How similar studies have performed: Prior research has reported brain and autonomic changes after COVID in some patients, but the specific neural mechanisms behind PASC-related fatigue remain incompletely clarified, so this trial builds on partial prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baltimore, Maryland
- Kennedy Krieger Institute — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Vikram Chib, PhD — Johns Hopkins University; Kennedy Krieger Institute
- Study coordinator: Anthony Gonzalez
- Email: gonzalezan@kennedykrieger.org
- Phone: 443-923-2716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PASC Post Acute Sequelae of COVID 19, Fatigue