Blood-Brain Barrier Integrity and Immune Dynamics in Neuropsychiatric Sequelae of Post-SARS-CoV-2 Onset ME/CFS Versus Pre-Pandemic ME/CFS Patients

NCT07256795 | Not Yet Recruiting DMC

• 1 other identifier: IRB00537228
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex chronic illness impacting multiple body systems and characterized by activity-limiting fatigue and post exertional symptom exacerbation, affecting over 3.5 million adults in the US and as many as half of those with long COVID. The mechanisms behind the frequently profound cognitive impairments in MECFS are elusive; however, disruption of the integrity of the blood brain barrier (BBB) and immune cell migration into the brain are thought to contribute to neuroinflammation and related neuropsychiatric burden in MECFS. This project combines brain imaging, neuropsychiatric assessments, and blood-based measures of inflammation in pre-pandemic and post-pandemic individuals with MECFS to understand the role of BBB permeability and inflammation as contributors to key aspects of cognition and mood.

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (2)

• Permeability Surface-Area Product (PS)

  Investigate BBB permeability in MECFS patients using WEPCAST MRI as measured by Permeability Surface-Area Product (PS)

  Up to 5 years

• Inflammatory biomarkers levels

  Inflammatory biomarkers levels and their relation to BBB or and its relationship to cognitive impairments

  Up to 5 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18-70 years of age * At least 8th grade education * Onset of the following symptoms prior to July 2019 (Pre-SARS-CoV-2 pandemic) and meeting 2015 IOM diagnostic criteria for MECFS:

You may qualify if:

• years of age
• At least 8th grade education
• Onset of the following symptoms prior to July 2019 (Pre-SARS-CoV-2 pandemic) and meeting 2015 IOM diagnostic criteria for MECFS:
• Substantial reduction in functioning and persistent and profound fatigue for at least 6 months. The person is unable to undertake the same level of activity before they became - . Their fatigue is not the result of significant exertion and is not substantially alleviated by rest.
• Post-exertional malaise.
• Unrefreshing sleep
• At least one of the following two symptoms:
• Cognitive impairment (difficulty with memory, finding words, understanding etc).
• Orthostatic intolerance (symptoms like palpitations, sweating, dizziness, nausea when standing that are reduced or eliminated when lying down).
• years of age
• At least 8th grade education
• Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the World Health Organization:
• Suspected case of SARS-CoV-2 infection
• Three options, A through C:
• Meets the clinical OR epidemiological criteria.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alba Azola, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Azola, MD

CONTACT

410 955 9229; aazola1@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04