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

Официальное название

Motivated Decision-Making and Performance

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Kennedy Krieger Institute — Baltimore

Идентификаторы

NCT: NCT07278388 · IRB00283000_1 · R01NS140610

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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