What this study is
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.
What's being tested
- High Density-Electroencephalogram
Intervention · PROCEDURE
EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
- Magnetic Resonance Imaging
Intervention · PROCEDURE
MRI scan of brain
- Blood specimen collection
Intervention · PROCEDURE
Blood will be collected from participants
- Pupillometry
Intervention · DIAGNOSTIC TEST
A pupillometer is a device that measures the size of the pupils.
Study details
- Sponsor
- University of Wisconsin, Madison
- Conditions
- Delirium
- Enrolling
- 468 people
- Starts
- 2017-02-13
- Est. completion
- 2029-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years and overSex ALLHealthy volunteers AcceptedCohort 1
You may qualify if
- Cohort 1: Age ≥65 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
You can't join if
- 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)
Cohort 2
You may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Wisconsin-Madison
Madison, Wisconsin, United States
- David Kunkel, BS · Contact608-262-6469dkunkel@wisc.edu
- Frankie Ingram, BS · Contact608-262-6469fingram@wisc.edu
- Robert Pearce, MD PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Wisconsin, Madison
Study ID 2015-0374
Principal investigator
Robert Pearce, MD, PhD
University of Wisconsin, Madison
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.