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Neural Mechanisms of Fatigue in Post-Acute Sequela of SARS-CoV-2
NCT07278388 · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
In plain English
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Official title
Motivated Decision-Making and Performance
About this study
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.
Eligibility 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.
Study design
Enrollment target: 200 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-16
Estimated completion: 2029-12-31
Last updated: 2025-12-12
Interventions
Behavioral: Physical Fatigue
Primary outcomes
- • Comparison between PASC and HC - difference in mean Assessment Error (Baseline, during experimental protocol.)
- • Comparing between PASC and HC - difference in BBB permeability (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 (Baseline, during experimental protocol.)
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · other
With: National Institute of Neurological Disorders and Stroke (NINDS)
Contacts & investigators
ContactAnthony Gonzalez · contact · gonzalezan@kennedykrieger.org · 443-923-2716
ContactVikram Chib, PhD · contact
InvestigatorVikram Chib, PhD · principal_investigator, Johns Hopkins University; Kennedy Krieger Institute
All locations (1)
Kennedy Krieger InstituteRecruiting
Baltimore, Maryland, United States