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Blood Brain Barrier Dysfunction and Postoperative Neurocognitive Disorders

NCT04566562 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-12-10

No results posted yet for this study

Summary

Postoperative neurocognitive disorders (PND), which include postoperative delirium and both acute and longlasting neurocognitive deficits, are a significant public health problem, leading to a cascade of deleterious complications. Older adults are particularly at-risk of developing PND both in the short and long term. Although age is consistently reported as an important risk factor, the exact pathophysiology of PND remains poorly understood, but may include postsurgery-compromised blood brain barrier (BBB) function. This project proposes that perioperative BBB dysfunction is associated with measurable brain morphologic findings in cognitive control areas that can be discovered with non-invasive magnetic resonance imaging (MRI). Patients scheduled for surgery with an age range of 65-75 years of age, will participate in brain diffusion-weighted pseudo-continuous arterial spin labeling (DW-pCASL) and diffusion tensor imaging (DTI), cognitive assessments, and evaluation of a BBB marker from blood (at baseline, at two weeks, and at six months after surgery).

All patients will have a brain scan (MRI) within before surgery and two weeks and six months after surgery. During this visit cognitive function will be assessed. Patients will also be asked to participate in a blood draw.

Conditions

  • Neurocognitive Disorders
  • Postoperative Cognitive Dysfunction

Interventions

DIAGNOSTIC_TEST

Brain Imaging

Magnetic Resonance Imaging (MRI) using diffusion weighted pseudo-continuous arterial spin labeling (DW-pCASL) .

DIAGNOSTIC_TEST

Cognitive Testing

Wide Range Assessment of Memory and Learning (WRAML 2) and Montreal Cognitive Assessment (MoCA)

DIAGNOSTIC_TEST

Blood Biomarkers

Inflammatory Markers

Sponsors & Collaborators

Principal Investigators

  • Rajesh Kumar, Ph.D · [email protected]

  • Susana Vacas, M.D., Ph.D. · Massachusetts General Hospital

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2024-01-30
Completion
2024-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566562 on ClinicalTrials.gov