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

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

Status: Enrolling

Conditions: PASC Post Acute Sequelae of COVID 19; Fatigue

Treatments: Behavioral: Physical Fatigue

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07278388

R01NS140610 (U.S. NIH Grant/Contract)

IRB00283000_1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

PASC Participants - Physical Fatigue Task

Experimental group

Description:

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

Treatment:

Behavioral: Physical Fatigue

Control Participants - Physical Fatigue Task

Experimental group

Description:

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

Treatment:

Behavioral: Physical Fatigue