Clinical Trial

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

Study acronym: MECFS BBB
Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-06-12
Trial Details
NCT Number NCT07256795
Lead Sponsor Johns Hopkins University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Chronic Fatigue Syndrome
Enrollment 200 participants
Start Date 2026-06-01
Primary Completion 2030-12 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-11