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Recruiting NCT07278388

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

No phase Interventional PASC Post Acute Sequelae of COVID 19 Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Fatigue.
Who it may be relevant to
Registry conditions: PASC Post Acute Sequelae of COVID 19, Fatigue. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Motivated Decision-Making and Performance

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Kennedy Krieger Institute — Baltimore

Identifiers

NCT: NCT07278388 · IRB00283000_1 · R01NS140610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗