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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
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The purpose of this project is to investigate the role of both neural inflammation and pre-existing neurodegenerative pathology in the risk and pathogenesis of post-operative cognitive dysfunction (POCD). To achieve this goal, the investigators will combine blood and cerebrospinal fluid (CSF) sampling, standardized cognitive tests, and dynamic neurophysiological markers of cortical network dysfunction in the form of event-related potentials (ERPs), to assess the link between neurodegeneration and neuroinflammation in the pathogenesis of POCD.
The purpose of this project is to investigate the role of both neural inflammation and pre-existing neurodegenerative pathology in the risk and pathogenesis of post-operative cognitive dysfunction (POCD) in 120 patients who will undergo a Total Knee Arthroscopy. The investigators will also explore neuropsychological, functional and biological measures as pre-operative risk indicators. To achieve this goal, the investigators will combine blood and cerebrospinal fluid (CSF) sampling, standardized cognitive tests, and dynamic neurophysiological markers of cortical network dysfunction in the form of event-related potentials (ERPs), to assess the link between neurodegeneration and neuroinflammation in the pathogenesis of POCD. To separate potential effects of general anesthesia from those of neuroinflammation, The investigators will recruit patients undergoing total knee replacement with the use of sedation and spinal anesthesia. To address the age risk factor, the investigators are targeting patients ages 60 and older. By using both validated and experimental biomarkers, this novel study design will isolate the effects of POCD due to systemic and neural inflammation and examine the links to pre-surgical cognitive impairment and underlying neurodegeneration as susceptibility factors.
Baseline (On the day of their final preoperative surgical visit prior to their TKA) the plan is to collect:
Cognitive assessments
a. Montreal Cognitive Assessment b. Stroop Test c. Symbol Digit Modalities Test d. Oral Trail Making Test
Collect two 4-ml blood samples for biomarker evaluation
Visit 2 Pre-op (day of scheduled TKA surgery) the plan is to collect:
Repeat cognitive testing
a. Montreal Cognitive Assessment b. Stroop Test c. Symbol Digit Modalities Test d. Oral Trail Making Test
Collect two 4-ml blood samples for biomarker evaluation
Collect 2cc of cerebral spinal fluid
Visit 2 Post-op:
Visit 3 (Forty-eight hours after discharge):
1. brief cognitive testing via telephone or video conferencing.
Blind Montreal Cognitive Assessment
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:
Visit 6 End of Study (At 6 months):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Post-Operative Cognitive Dysfunction | Subjects determined to have post-operative cognitive dysfunction based on the results of:
All subjects will undergo:
|
| |
| Without Post-Operative Cognitive Dysfunction | Subjects determined to not have post-operative cognitive dysfunction based on the results of:
All subjects will undergo:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montreal Cognitive Assessment | Behavioral | Cognitive evaluation of short term memory, visuospatial abilities, executive functioning, attention, concentration, working memory, language, and orientation to time and place |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Interleukin-1 beta (IL-1β) | A proinflammatory cytokine that activates astrocytes and micro ganglia | Baseline |
| Blood Interleukin-1 beta (IL-1β) | A proinflammatory cytokine that activates astrocytes and micro ganglia | Pre-op (pre-operation) -Visit 2- Day of surgery |
| Blood Interleukin-1 beta (IL-1β) | A proinflammatory cytokine that activates astrocytes and micro ganglia | Post-op Visit 2- In recovery room up to 12 hours post surgery |
| Blood Interleukin-1 beta (IL-1β) | A proinflammatory cytokine that activates astrocytes and micro ganglia | 2 Week Post-op -Visit 4 |
| Blood Interleukin-1 beta (IL-1β) | A proinflammatory cytokine that activates astrocytes and micro ganglia | 6 Week Post-op -Visit 5 |
| Blood Tumor necrosis factor alpha (TNF- α) | A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases | Baseline |
| Blood Tumor necrosis factor alpha (TNF- α) | A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases | Pre-op- Visit 2- Day of surgery |
| Blood Tumor necrosis factor alpha (TNF- α) |
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Inclusion Criteria:
Exclusion Criteria:
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No one ethnic group is either targeted or excluded in the proposed study. The investigators aim to target a sample of individuals ages 60 and older who will all undergo total knee arthroplasty. This selection of participants is based upon the aims of the current study.
Due to the nature of the study, the investigators will include individuals with who are considered elderly. This population is necessary due to the increased prevalence of POCD within this group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Department of Anesthesiology Chair | Contact | 8653059220 | rcraft@utmck.edu | |
| Aimee Pehrson, MPH | Contact | 8653055432 | apehrson@utmck.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert M Craft, MD | University of Tennessee Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert M Craft | Recruiting | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31166241 | Background | Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729. | |
| 27537541 |
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Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
Investigators who proposed use of the data has been approved by an independent review committee identified for this purpose.
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Serum, plasma and cerebrospinal fluid.
|
| Stroop Test | Behavioral | Evaluates Processing Speed and Executive Control |
|
| 4AT Delirium | Diagnostic Test | Screening tool to test for delirium post surgery |
|
| Grooved Pegboard | Behavioral | Evaluation testing for dominant and non dominant sensory-motor speed |
|
| NACC Cognitive Battery | Behavioral | A series of tests that evaluate attention, concentration, immediate verbal memory, immediate visual memory, discrimination, processing/motor speed, and validity and effort. |
|
| ERP Testing | Diagnostic Test | 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 | Diagnostic Test | Up to six 4 ml samples of both serum and plasma will be obtained to assess for inflammatory markers. |
|
| Cerebral Spinal Fluid Sample | Diagnostic Test | At the time the spinal is placed for anesthetic purposes, 2ml of cerebral spinal fluid will be obtained to assess for inflammatory markers. |
|
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases |
| Post-op Visit 2- In recovery room up to 12 hours post surgery |
| Blood Tumor necrosis factor alpha (TNF- α) | A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases | 2-week Post-op Visit 4 |
| Blood Tumor necrosis factor alpha (TNF- α) | A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases | 6-week Post-op Visit 5 |
| Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha) | A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease | Baseline |
| Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha) | A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease | Pre-op Visit 2- Day of surgery |
| Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha) | A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease | Post-op Visit 2- In recovery room up to 12 hours post surgery |
| Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha) | A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease | 2-week Post-op Visit 4 |
| Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha) | A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease | 6- week Post-op Visit 5 |
| Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2) | A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages | Baseline |
| Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2) | A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages | Pre-op Visit 2- Day of surgery |
| Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2) | A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages | Post-op Visit 2- In recovery room up to 12 hours post surgery |
| Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2) | A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages | 2 week Post-op Visit 4 |
| Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2) | A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages | 6 week- Post-op Visit 5 |
| Cerebral Spinal Fluid Phosphorylated Tau Protein | A helical protein known to be a biomarker in the cerebral spinal fluid in brains with Alzheimer's Disease | Pre-op Visit 2-Day of surgery |
| ERP response amplitude | Measurement of event related potentials in the brain | 6 Week post-op visit 5 |
| ERP response latency | Measurement of event related potentials in the brain | 6 Week post-op visit 5 |
| ERP response amplitude | Measurement of event related potentials in the brain | 6 Month post-op visit 6 |
| ERP response latency | Measurement of event related potentials in the brain | 6 Month post-op visit 6 |
| Stroop Test | A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal." | Baseline |
| Stroop Test | A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal." | Pre-op Visit 2- Day of surgery |
| Stroop Test | A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal." | 2 Week post-op Visit 4 |
| Montreal Cognitive Assessment | A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-30 with a score >26 being normal. | Baseline |
| Montreal Cognitive Assessment | A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-30 with a score >26 being normal. | Pre-op Visit 2- Day of surgery |
| Blind Montreal Cognitive Assessment | A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-22 with a score >18 being normal. | 48 Hours post-op- Visit 3 |
| Montreal Cognitive Assessment | A neurocognitive test used to assess cognitive function across multiple domains. Scoring is on a scale from 0-30 with a score >26 being normal. | 2 Week post-op- Visit 4 |
| Oral Trail Making Test | A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient. | Baseline |
| Oral Trail Making Test | A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient. | Pre-op Visit 2- Day of surgery |
| Oral Trail Making Test | A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient. | 48 Hours post-op Visit 3 |
| Oral Trail Making Test | A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient. | 2- Week post-op Visit 4 |
| Symbol Digit Test | A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality. | Baseline |
| Symbol Digit Test | A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality. | Pre-op Visit 2- Day of surgery |
| Symbol Digit Test | A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality. | 2- Week post-op Visit 4 |
| 4 AT Delirium Screening | Bedside screening to detect delirium with a score of 4 or more indicating delirium +/- cognitive impairment, and a score of 1-3 indicating possible cognitive impairment. | Post-op Visit 2- In recovery room up to 12 hours post surgery |
| Grooved Pegboard Test | A neurocognitive test consisting of varying key shapes and matching holes used to test visual motor coordination with a higher score indicating less or no impairment based on the individual's age and sex. | 6 month post-op Visit 6 |
| National Alzheimer's Coordinating Center Cognitive Battery | Cognitive assessment to test for deficits across multiple domains with a score of 95/995 =physical problem; 96/996 = cognitive/behavioral problem | 6 month post-op Visit 6 |
| Background |
| O' Brien H, Mohan H, Hare CO, Reynolds JV, Kenny RA. Mind Over Matter? The Hidden Epidemic of Cognitive Dysfunction in the Older Surgical Patient. Ann Surg. 2017 Apr;265(4):677-691. doi: 10.1097/SLA.0000000000001900. |
| 23371369 | Background | Chen MH, Liao Y, Rong PF, Hu R, Lin GX, Ouyang W. Hippocampal volume reduction in elderly patients at risk for postoperative cognitive dysfunction. J Anesth. 2013 Aug;27(4):487-92. doi: 10.1007/s00540-012-1548-6. Epub 2013 Jan 31. |
| 28465805 | Background | Pappa M, Theodosiadis N, Tsounis A, Sarafis P. Pathogenesis and treatment of post-operative cognitive dysfunction. Electron Physician. 2017 Feb 25;9(2):3768-3775. doi: 10.19082/3768. eCollection 2017 Feb. |
| 31976614 | Background | Xiao QX, Liu Q, Deng R, Gao ZW, Zhang Y. Postoperative cognitive dysfunction in elderly patients undergoing hip arthroplasty. Psychogeriatrics. 2020 Jul;20(4):501-509. doi: 10.1111/psyg.12516. Epub 2020 Jan 24. |
| 28302254 | Background | Feinkohl I, Winterer G, Spies CD, Pischon T. Cognitive Reserve and the Risk of Postoperative Cognitive Dysfunction. Dtsch Arztebl Int. 2017 Feb 17;114(7):110-117. doi: 10.3238/arztebl.2017.0110. |
| 21474666 | Background | Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7. |
| 20858956 | Background | Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086. |
| 31561651 | Background | Edipoglu IS, Celik F. The Associations Between Cognitive Dysfunction, Stress Biomarkers, and Administered Anesthesia Type in Total Knee Arthroplasties: Prospective, Randomized Trial. Pain Physician. 2019 Sep;22(5):495-507. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| D057190 | Stroop Test |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided