Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT03124303

Conditions

Delirium

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

High Density-Electroencephalogram

Magnetic Resonance Imaging

Blood specimen collection

Pupillometry

Study Details

Brief summary:

The IPOD-B3 study aims to characterize the relationship between premorbid brain activity and postoperative delirium in patients undergoing major surgery. This is a expansion of the NeuroVISION Bolt-On study, NCT01980511.

Conditions

Delirium

Study ID

NCT03124303

Start date

Feb 13, 2017

Status verified date

Dec, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

468 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants 1-320

First 320 participants enrolled

Participants 321-470

Final 150 participants enrolled

Interventions

High Density-Electroencephalogram

EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium

Magnetic Resonance Imaging

MRI scan of brain

Blood specimen collection

Blood will be collected from participants

Pupillometry

A pupillometer is a device that measures the size of the pupils.

Primary outcome measure

  • Functional Connectivity [ Time Frame: Pre-operative measure: Up to 4 weeks prior to surgery. Post-operative measure: Post-Operative days 1-4 ]
  • Brain state change [ Time Frame: Post-operative day 1 through 4 ]

Central Contacts and Locations

Central contacts

David Kunkel, BS

608-262-6469dkunkel@wisc.edu

Frankie Ingram, BS

608-262-6469fingram@wisc.edu

Locations

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

David Kunkel, BS

608-262-6469dkunkel@wisc.edu

Frankie Ingram, BS

608-262-6469fingram@wisc.edu

Principal Investigator:

Robert Pearce, MD PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2025-12-15.