Study To Analyze Memory/Thinking Problems In Older Adults After Surgery (POCD)

July 5, 2019 updated by: University of Florida

Neuroimaging Biomarkers for Post-Operative Cognitive Decline in Older Adults

The purpose of the study is to examine specific neuroimaging predictors of memory and executive decline in older adults at various stages after total knee replacement surgery.

Study Overview

Detailed Description

Cognitive impairment after major cardiac or non-cardiac surgery occurs in a high rate for older adults. The results of previous studies indicate that certain neuro-imaging markers can determine which individuals pose a greater risk for memory and thinking changes after surgery. Based on a pilot study, there is evidence that pre-surgical neuroimaging biomarkers associate with memory and executive decline after a well controlled surgical procedure (total knee antroplasty). In this study, researchers will use brain imaging studies to determine which patients are most likely to be affected by cognitive changes after this type of surgery. The use of Magnetic Resonance Imaging (MRI) will help investigators identify brain biomarkers that are associated with cognitive problems, such as white matter abnormalities and changes to small blood vessels. Patients undergoing total knee replacement surgery, as well as a group of non-surgery participants of similar age, education and health status,will receive cognitive testing and MRI brain scans before and after surgery/non-surgery. Researchers will compare and monitor both groups up to one year after surgery/non-surgery.

Prior to enrollment, participants will be asked to review the informed consent and provide written consent to participate in the study. The enrollment phase will involve in-person baseline assessment of cognitive functioning within two weeks of the scheduled surgery/non-surgery in order to rule out exclusion criteria. Testing will be in cooperation with the University of Florida General Clinical Research Center. Post-baseline MRI will be conducted on all participants (surgery/control) within 48 hours of the surgery/pseudo-surgery date to identify acute stroke differences from baseline. Cognitive assessments will be conducted for each participant at three-weeks, three-months, and one-year after surgery.

The research is highly significant because it will be the first study to use in-vivo diffusion imaging methods to examine the contribution of specific presurgical neuroanatomical vulnerabilities on executive and memory cognitive decline after one of the most common orthopedic surgeries sought by older adults. Additionally, it will be the first study to examine how specific neuroimaging biomarkers interact negatively with specific peri-operative variables including emboli number during surgery, embolic changes to the brain, anesthesia depth, and cerebral oxygenation.

The findings of the study will improve pre-surgery screening procedures for older adults and assist with the development of peri-operative interventions that will prevent neurodegenerative disease acceleration.

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Two age-matched participant groups will be recruited. Healthy non-demented age matched patients undergoing elective total knee arthoplasty, and age, education, and diseased matched (osteoarthritis knee pain;) non-surgery peers.

Description

Inclusion Criteria:

  • Planned total unilateral knee antroplasty or non-surgical knee osteoarthritis
  • Age 60 years or older at the time of baseline assessment
  • Telephone screening and in-person baseline cognitive testing not supportive of dementia
  • Handedness: Right handed; restriction to left-right hemisphere laterality and white matter pathways
  • Participant and family deny presence of difficulties with Instrumental Activities of Daily Living (IADL)
  • All ethnic and racial groups will be recruited

Exclusion Criteria:

  • Underlying medical diseases likely to limit lifespan or confound outcome analyses:

    1. cancer requiring treatment in past five years
    2. serious infectious diseases
    3. congestive heart failure
    4. chronic hepatitis
    5. history of organ transplantation
    6. seizure disorders
    7. history of head trauma resulting in intensive care
    8. current diagnosis of alcoholism, drug dependence, history of major tranquilizer use
  • Neurodegenerative Exclusions:

    1. history of major stroke
    2. exposure to toxins or neuroleptics
    3. history of encephalitis
    4. neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear palsy, or significant orthostatic hypertension
    5. signs of dementia.
  • Psychiatric Exclusions:

    1. major psychiatric disorder
    2. major depression
  • Conditions or behaviors likely to affect imaging or cognitive testing:

    1. claustrophobia
    2. non-medical bodily metal, pace-maker device
    3. less than five years of formal education
    4. inability to read or write
    5. self-reported hearing difficulty that interferes with standardized test administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery
80 patients will undergo total knee replacement surgery; two Magnetic Resonance Imaging scans; cognitive assessment testing.
Both groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery.
Other Names:
  • MRI
Both groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year.
Other Names:
  • Cognitive assessement tests
Non-Surgery
80 non-surgery participants will be included as part of the control group; two Magnetic Resonance Imaging scans; cognitive assessment testing.
Both groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery.
Other Names:
  • MRI
Both groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year.
Other Names:
  • Cognitive assessement tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicting Executive Decline
Time Frame: baseline, 3 weeks, 3 months, 1 year
Severity of pre-surgical/baseline neuroimaging markers of cerebrovascular disease will predict post-operative executive decline at 3 weeks, 3 months and 1 year.
baseline, 3 weeks, 3 months, 1 year
Predicting Memory Decline
Time Frame: baseline, 3 weeks, 3 months, 1 year
Pre-surgical/baseline neuroimaging markers of entorhinal-hippocampal white matter connectivity will predict post-operative memory decline at 3 weeks, 3 months and 1 year.
baseline, 3 weeks, 3 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Catherine Price, Ph.D, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2013

Primary Completion (Actual)

June 21, 2018

Study Completion (Actual)

July 21, 2018

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IRB201601040-N
  • R01NR014181-01 (U.S. NIH Grant/Contract)
  • 487-2012 (Other Identifier: UF legacy)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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