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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by University of Florida
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01786577
First received: January 30, 2013
Last updated: July 26, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Post-Operative Cognitive Decline in Older Adults
Other: Magnetic Resonance Imaging
Behavioral: Cognitive assessment testing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Neuroimaging Biomarkers for Post-Operative Cognitive Decline in Older Adults

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Predicting Executive Decline [ Time Frame: baseline, 3 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
    Severity of pre-surgical/baseline neuroimaging markers of cerebrovascular disease will predict post-operative executive decline at 3 weeks, 3 months and 1 year.

  • Predicting Memory Decline [ Time Frame: baseline, 3 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: March 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery
80 patients will undergo total knee replacement surgery; two Magnetic Resonance Imaging scans; cognitive assessment testing.
Other: Magnetic Resonance Imaging
Both groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery.
Other Name: MRI
Behavioral: Cognitive assessment testing
Both groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year.
Other Name: Cognitive assessement tests
Active Comparator: Non-Surgery
80 non-surgery participants will be included as part of the control group; two Magnetic Resonance Imaging scans; cognitive assessment testing.
Other: Magnetic Resonance Imaging
Both groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery.
Other Name: MRI
Behavioral: Cognitive assessment testing
Both groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year.
Other Name: Cognitive assessement tests

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.

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786577

Contacts
Contact: Donna Weber, BA 352-273-5929 dhweber@phhp.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Catherine Price, Ph.D    352-273-5929    Cep23@ufl.edu   
Contact: Donna Weber, B.A..    352-273-5929    dhweber@phhp.ufl.edu   
Principal Investigator: Catherine Price, Ph.D         
Sponsors and Collaborators
University of Florida
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Catherine Price, Ph.D University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01786577     History of Changes
Other Study ID Numbers: 487-2012  R01NR014181-01 
Study First Received: January 30, 2013
Last Updated: July 26, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Neuroimaging Biomarkers
Cognitive Decline in Elderly
Memory, Thinking problems for Older Adults
Executive Decline
Post-operative cognitive change

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2016