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

NCT ID: NCT07278388

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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PASC Post Acute Sequelae of COVID 19 Fatigue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PASC Participants - Physical Fatigue Task

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

Group Type EXPERIMENTAL

Physical Fatigue

Intervention Type BEHAVIORAL

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

Control Participants - Physical Fatigue Task

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

Group Type EXPERIMENTAL

Physical Fatigue

Intervention Type BEHAVIORAL

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

Interventions

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Physical Fatigue

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikram Chib, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University; Kennedy Krieger Institute

Locations

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Kennedy Krieger Institute

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anthony Gonzalez

Role: CONTACT

443-923-2716

Vikram Chib, PhD

Role: CONTACT

Facility Contacts

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Anthony Gonzalez

Role: primary

443-923-2716

Other Identifiers

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R01NS140610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00283000_1

Identifier Type: -

Identifier Source: org_study_id

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