Blood Brain Barrier Dysfunction and Postoperative Neurocognitive Disorders

NCT04566562 | Completed

• 1 other identifier: BBBSx 20-001456
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

brain imaging, neurocognitive testing

Outcome Measures

Primary Outcomes (6)

• Preoperative cognitive function

  Montreal Cognitive Assessment (MoCA) test

  pre-surgery (within five days before)

• Postoperative cognitive dysfunction - delayed cognitive recovery

  Montreal Cognitive Assessment (MoCA) test

  Post-surgery (within two weeks post surgery)

• Postoperative cognitive dysfunction - neurocognitive disorder

  Montreal Cognitive Assessment (MoCA) test

  Post-surgery (6 months after surgery)

• Preoperative cognitive function II

  Wide Range Assessment of Memory and Learning (WRAML2)

  Pre-surgery (within five days before surgery)

• Postoperative cognitive dysfunction - delayed cognitive recovery II

  Wide Range Assessment of Memory and Learning (WRAML2)

  Post-surgery (within two weeks post surgery)

• Postoperative cognitive dysfunction - neurocognitive disorder II

  Assessment of Memory and Learning (WRAML2)

  Post-surgery (6 months after surgery)

Secondary Outcomes (5)

• Blood Serum anti-inflammatory Biomarkers

  pre- (within five days before surgery)

• Blood Serum anti-inflammatory Biomarkers II

  post-surgery (within two weeks of surgery)

• Brain changes

  pre- surgery (within five days before)

• Brain changes II

  Post-surgery (within two days post surgery)

• Brain changes III

  Post-surgery (within six months post surgery)

Study Arms (1)

Study Group

Brain scans, cognitive tests, blood biomarkers

Diagnostic Test: Brain Imaging; Diagnostic Test: Cognitive Testing; Diagnostic Test: Blood Biomarkers

Interventions

Brain Imaging DIAGNOSTIC_TEST

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

Study Group

Cognitive Testing DIAGNOSTIC_TEST

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

Study Group

Blood Biomarkers DIAGNOSTIC_TEST

Inflammatory Markers

Study Group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of either sex, in the age range 65-75 years scheduled for abdominal, gynecologic or urologic surgery.

You may qualify if:

• years old
• Scheduled for abdominal, gynecologic or urological surgery

You may not qualify if:

• Subjects undergoing surgery with a previous history of stroke, myocardial infarction, current pregnancy (if female), diagnosed neuropsychological and neuropsychiatric diseases, airway or chest deformities that would interfere with breathing, chronic obstructive pulmonary disease, cystic fibrosis, presence of space-occupying brain lesions, any history of drug abuse (e.g., cocaine or tobacco use), chronic kidney disease requiring dialysis.
• Body weight \>300 pounds (restrictions of MRI scanner table).
• All subjects with any contraindication to the MRI procedures, such as metallic and electronic implants (phrenic or cardiac pacemakers), claustrophobia, metallic-based tattoos, will also be excluded. Non-english speaking patients will also be excluded as the cognitive tests have not been validated in other languages.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Neurocognitive Disorders; Postoperative Cognitive Complications

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Rajesh Kumar, Ph.D

  rkumar@mednet.ucla.edu

  PRINCIPAL INVESTIGATOR

• Susana Vacas, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor In-Residence

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: August 3, 2020
• Primary Completion: January 30, 2024
• Study Completion: February 29, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-08

Locations

US (1)