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Observational Study on Postoperative Delirium and Brain Activity

This study, called IPOD-B3, is looking at the connection between your brain activity before surgery and whether you develop delirium (a state of confusion) after major surgery. Researchers will use several methods to gather information, including a High Density-Electroencephalogram (EEG) to measure brain waves, a Magnetic Resonance Imaging (MRI) scan of your brain, blood collection, and pupillometry (measuring pupil size). The study aims to understand how brain activity changes and how different parts of the brain communicate (functional connectivity) before and after surgery. You may be able to join if you are 60 years or older and are having major surgery that requires at least a two-day hospital stay. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 468 participants. It is not specified if participants are randomly assigned to groups or if the study is blinded.
What's involved
You would have measurements taken up to four weeks before surgery and again on days 1-4 after surgery. These measurements include EEG, MRI, blood collection, and pupillometry.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for brain state changes and functional connectivity from post-operative day 1 through day 4.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03124303

Interventions for Postoperative Delirium: Biomarker-3

Recruiting
Not specifiedAges 60+Observational
University of Wisconsin, Madison
~468 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:High Density-ElectroencephalogramMagnetic Resonance ImagingBlood specimen collectionPupillometry

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Functional Connectivity
Measured over Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4
+1 more outcome measured

Conditions

Delirium

Explore related trials

Delirium

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Robert Pearce, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

David Kunkel, BS
[email protected]
608-262-6469
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cohort 1: Age ≥65 years
Cohort 2: Age ≥60 years
Anticipated length of hospital stay of at least 2 days after surgery that occurs under general or neuraxial anesthesia
Written Informed Consent for potential participation prior to surgery

Exclusion

Contraindication to EEG
Unable or unwilling to attend the follow-up appointments
Documented history of dementia
Deemed incapable of providing consent by surgical team
Residing in a nursing home
Undergoing intracranial surgery
Unable to complete neurocognitive testing due to language, vision or hearing impairment
Unable to communicate with the research staff due to language barriers
For optional MRI portion of the study: Contraindication to MRI (e.g., implanted devices not safe for MRI studies, claustrophobia, unable to lie flat or still)

What this trial measures

  • Functional ConnectivityPre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4

    Change from baseline functional connectivity at immediate postoperative period and association between delirium (CAM) and functional connectivity of the cingulate cortex

  • Brain state changePost-operative day 1 through 4

    Quantified by the MSD across regions of interest from resting state time-series to randomly spaced points across the time-series. Measured for Cohort 2 only.