Health TrialsbyHealthPanel

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

ConditionsPASC Post Acute Sequelae of COVID 19Fatigue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physical Fatigue

    Behavioral

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: PASC Participants - Physical Fatigue TaskExperimental treatment 1 intervention
Group B: Control Participants - Physical Fatigue TaskExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Comparison between PASC and HC - difference in mean Assessment Error

The difference between the level of effort rated by participants, and their average grip force exerted on a grip force dynamometer. Compared between PASC and HC.

Time frame
Baseline, during experimental protocol.
2

Comparing between PASC and HC - difference in BBB permeability

Collected from and MRI sequence designed to measure BBB permeability.

Time frame
Baseline, during MRI acquisition.
3

Comparing between PASC and HC - Regions of the brain that are sensitive to Assessment error as a function of disease state

We will examine an fMRI contrast, at the time of effort assessment, between HC and PASC groups. This contrast will examine percent signal change in brain activity.

Time frame
Baseline, during experimental protocol.
4

The modulatory effect of BBB permeability on the relationship between Neural Activity and Effort Assessment

We will create a structural equation model that includes BBB permeability, fMRI activity, effort assessment behavior, and disease state (PASC/HC).

Time frame
Baseline, during experimental protocol and MRI aquisition.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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