Study Results
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Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2021-11-01
2022-09-30
Brief Summary
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Detailed Description
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Baseline (On the day of their final preoperative surgical visit prior to their TKA) the plan is to collect:
1. Cognitive assessments
a. Montreal Cognitive Assessment b. Stroop Test c. Symbol Digit Modalities Test d. Oral Trail Making Test
2. Collect two 4-ml blood samples for biomarker evaluation
Visit 2 Pre-op (day of scheduled TKA surgery) the plan is to collect:
1. Repeat cognitive testing
a. Montreal Cognitive Assessment b. Stroop Test c. Symbol Digit Modalities Test d. Oral Trail Making Test
2. Collect two 4-ml blood samples for biomarker evaluation
3. Collect 2cc of cerebral spinal fluid
Visit 2 Post-op:
1. 4 AT test for delirium
2. Collect two 4ml blood samples will be taken
Visit 3 (Forty-eight hours after discharge):
1\. brief cognitive testing via telephone or video conferencing.
1. Blind Montreal Cognitive Assessment
2. Oral Trail Making Test
Visit 4 (two weeks for their post-operative visit):
1\. Repeat cognitive testing
1\. Montreal Cognitive Assessment 2. Stroop Test 3. Symbol Digit Modalities Test 2. Oral Trail Making Test 3. Collect two 4ml blood samples for biomarker testing.
For patients who had pre-operative cognitive impairment, their participation in the study will end here
For 20 participants with no indication of pre-surgical cognitive impairment (10 with no post-operative impairment and 10 with presumed POCD)
Visit 5 (\~ 6 weeks post-op) the plan is to collect:
1. Complete initial neurophysiological recording of event-related potentials (ERPs). This ERP session is performed to establish baseline cortical network function. Neurophysiological studies will be conducted using a 128-electrode EEG system.
2. Collect two 4-ml blood samples
Visit 6 End of Study (At 6 months):
1. Collect a final assessment of cognition
2. ERP assessment
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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With Post-Operative Cognitive Dysfunction
Subjects determined to have post-operative cognitive dysfunction based on the results of:
1. 4AT Delirium Test
2. Scoring on :
1. Montreal Cognitive Assessment
2. Oral Trails Test
3. Stroop Test
4. Symbol Digit Modalities Test
All subjects will undergo:
1. Blood sample collection
2. Cerebral spinal fluid collection
3. ERP testing
4. NACC Cognitive Battery
5. Grooved Pegboard testing
Montreal Cognitive Assessment
Cognitive evaluation of short term memory, visuospatial abilities, executive functioning, attention, concentration, working memory, language, and orientation to time and place
Stroop Test
Evaluates Processing Speed and Executive Control
4AT Delirium
Screening tool to test for delirium post surgery
Grooved Pegboard
Evaluation testing for dominant and non dominant sensory-motor speed
NACC Cognitive Battery
A series of tests that evaluate attention, concentration, immediate verbal memory, immediate visual memory, discrimination, processing/motor speed, and validity and effort.
ERP Testing
An event-related potential ( ERP) is the measured brain response that is the direct result of a specific sensory, cognitive, or motor event. More formally, it is any stereotyped electrophysiological response to a stimulus. The study of the brain in this way provides a noninvasive means of evaluating brain functioning.
Blood Plasma and Serum sampling
Up to six 4 ml samples of both serum and plasma will be obtained to assess for inflammatory markers.
Cerebral Spinal Fluid Sample
At the time the spinal is placed for anesthetic purposes, 2ml of cerebral spinal fluid will be obtained to assess for inflammatory markers.
Without Post-Operative Cognitive Dysfunction
Subjects determined to not have post-operative cognitive dysfunction based on the results of:
1. 4AT Delirium Test
2. Scoring on :
1. Montreal Cognitive Assessment
2. Oral Trails Test
3. Stroop Test
4. Symbol Digit Modalities Test
All subjects will undergo:
1. Blood sample collection
2. Cerebral spinal fluid collection
3. ERP testing
4. NACC Cognitive Battery
5. Grooved Pegboard testing
Montreal Cognitive Assessment
Cognitive evaluation of short term memory, visuospatial abilities, executive functioning, attention, concentration, working memory, language, and orientation to time and place
Stroop Test
Evaluates Processing Speed and Executive Control
4AT Delirium
Screening tool to test for delirium post surgery
Grooved Pegboard
Evaluation testing for dominant and non dominant sensory-motor speed
NACC Cognitive Battery
A series of tests that evaluate attention, concentration, immediate verbal memory, immediate visual memory, discrimination, processing/motor speed, and validity and effort.
ERP Testing
An event-related potential ( ERP) is the measured brain response that is the direct result of a specific sensory, cognitive, or motor event. More formally, it is any stereotyped electrophysiological response to a stimulus. The study of the brain in this way provides a noninvasive means of evaluating brain functioning.
Blood Plasma and Serum sampling
Up to six 4 ml samples of both serum and plasma will be obtained to assess for inflammatory markers.
Cerebral Spinal Fluid Sample
At the time the spinal is placed for anesthetic purposes, 2ml of cerebral spinal fluid will be obtained to assess for inflammatory markers.
Interventions
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Montreal Cognitive Assessment
Cognitive evaluation of short term memory, visuospatial abilities, executive functioning, attention, concentration, working memory, language, and orientation to time and place
Stroop Test
Evaluates Processing Speed and Executive Control
4AT Delirium
Screening tool to test for delirium post surgery
Grooved Pegboard
Evaluation testing for dominant and non dominant sensory-motor speed
NACC Cognitive Battery
A series of tests that evaluate attention, concentration, immediate verbal memory, immediate visual memory, discrimination, processing/motor speed, and validity and effort.
ERP Testing
An event-related potential ( ERP) is the measured brain response that is the direct result of a specific sensory, cognitive, or motor event. More formally, it is any stereotyped electrophysiological response to a stimulus. The study of the brain in this way provides a noninvasive means of evaluating brain functioning.
Blood Plasma and Serum sampling
Up to six 4 ml samples of both serum and plasma will be obtained to assess for inflammatory markers.
Cerebral Spinal Fluid Sample
At the time the spinal is placed for anesthetic purposes, 2ml of cerebral spinal fluid will be obtained to assess for inflammatory markers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects scheduled to undergo TKA
* Fluent and literate in English
* Able to give consent for themselves based upon the MacArthur Competence Assessment Tool for Clinical Research
* Able to have a subarachnoid block with only intravenous sedation
Exclusion Criteria
* Cognitively impaired to the point where they are unable to give consent for themselves
* Blindness or partial blindness
* Pre-existing neurodegenerative conditions
* Contraindication for subarachnoid block and/or requiring general anesthesia
60 Years
ALL
Yes
Sponsors
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Alzheimer's Association
OTHER
University of Tennessee Graduate School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Robert M Craft, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee Graduate School of Medicine
Locations
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Robert M Craft
Knoxville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Robert M Craft, MD
Role: primary
References
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Other Identifiers
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4790
Identifier Type: -
Identifier Source: org_study_id
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