Post-Operative ConfusionPOCDNCT05378659
Neuroinflammation and Alzheimer's Pathology in POCD
An observational study of Post-Operative Confusion and Neuroinflammatory Response, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Operative Confusion, Neuroinflammatory Response, Alzheimer Disease
- What is being tested?
- Montreal Cognitive Assessment, Stroop Test and 4AT Delirium
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Males and females 60 years or older in age
- 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
Who cannot join
- Less than 60 years of age
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Robert M Craft
Knoxville, Tennessee, 37920
Robert M Craft, MD, 865-305-9220
Aimee Pehrson, MPH, 8653055432, apehrson@utmck.edu
About this study
Official title: Neuroinflammation and Alzheimer's Pathology in Post-operative Cognitive Dysfunction: A Pilot Study
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.
Read the detailed description
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
- 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
- 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:
- 4 AT test for delirium
- Collect two 4ml blood samples will be taken
Visit 3 (Forty-eight hours after discharge):
- 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):
- Repeat cognitive testing
- 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:
- 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.
- Collect two 4-ml blood samples Visit 6 End of Study (At 6 months):
- Collect a final assessment of cognition
- ERP assessment
- Being tested
- Montreal Cognitive Assessment, Stroop Test, 4AT Delirium, Grooved Pegboard, NACC Cognitive Battery
- Keywords
- POCD, Neuroinflammation
- Medical subject headings
- Alzheimer Disease, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal Cognitive AssessmentBehavioural
Also called MOCA
Cognitive evaluation of short term memory, visuospatial abilities, executive functioning, attention, concentration, working memory, language, and orientation to time and place
Stroop TestBehavioural
Evaluates Processing Speed and Executive Control
4AT DeliriumDiagnostic test
Screening tool to test for delirium post surgery
Grooved PegboardBehavioural
Evaluation testing for dominant and non dominant sensory-motor speed
NACC Cognitive BatteryBehavioural
A series of tests that evaluate attention, concentration, immediate verbal memory, immediate visual memory, discrimination, processing/motor speed, and validity and effort.
ERP TestingDiagnostic 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 samplingDiagnostic test
Up to six 4 ml samples of both serum and plasma will be obtained to assess for inflammatory markers.
Cerebral Spinal Fluid SampleDiagnostic test
At the time the spinal is placed for anesthetic purposes, 2ml of cerebral spinal fluid will be obtained to assess for inflammatory markers.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Montreal Cognitive Assessment; Behavioral: Stroop Test; Diagnostic Test: 4AT Delirium; Behavioral: Grooved Pegboard; Behavioral: NACC Cognitive Battery; Diagnostic Test: ERP Testing; Diagnostic Test: Blood Plasma and Serum sampling; Diagnostic Test: Cerebral Spinal Fluid Sample | |
| 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 Receives: Behavioral: Montreal Cognitive Assessment; Behavioral: Stroop Test; Diagnostic Test: 4AT Delirium; Behavioral: Grooved Pegboard; Behavioral: NACC Cognitive Battery; Diagnostic Test: ERP Testing; Diagnostic Test: Blood Plasma and Serum sampling; Diagnostic Test: Cerebral Spinal Fluid Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Interleukin-1 beta (IL-1β)
A proinflammatory cytokine that activates astrocytes and micro ganglia
Measured: Baseline
Blood Interleukin-1 beta (IL-1β)
A proinflammatory cytokine that activates astrocytes and micro ganglia
Measured: Pre-op (pre-operation) -Visit 2- Day of surgery
Blood Interleukin-1 beta (IL-1β)
A proinflammatory cytokine that activates astrocytes and micro ganglia
Measured: 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
Measured: 2 Week Post-op -Visit 4
Blood Interleukin-1 beta (IL-1β)
A proinflammatory cytokine that activates astrocytes and micro ganglia
Measured: 6 Week Post-op -Visit 5
Blood Tumor necrosis factor alpha (TNF- α)
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Measured: Baseline
Blood Tumor necrosis factor alpha (TNF- α)
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Measured: Pre-op- Visit 2- Day of surgery
Blood Tumor necrosis factor alpha (TNF- α)
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Measured: 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
Measured: 2-week Post-op Visit 4
Blood Tumor necrosis factor alpha (TNF- α)
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Measured: 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
Measured: Baseline
Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)
A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-op Visit 2-Day of surgery
ERP response amplitude
Measurement of event related potentials in the brain
Measured: 6 Week post-op visit 5
ERP response latency
Measurement of event related potentials in the brain
Measured: 6 Week post-op visit 5
ERP response amplitude
Measurement of event related potentials in the brain
Measured: 6 Month post-op visit 6
ERP response latency
Measurement of event related potentials in the brain
Measured: 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."
Measured: Baseline
Stroop Test
A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 month post-op Visit 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Nov 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Post-Operative ConfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Robert M Craft, MD, Principal investigator, University of Tennessee Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378659
- Sponsor's protocol ID
- 4790
- Acronym
- POCD
- Status last verified
- May 2022
- First submitted
- 25 Apr 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 31166241O' 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.
PubMed 27537541Chen 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.
PubMed 23371369Pappa 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.
PubMed 28465805Xiao 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.
PubMed 31976614Feinkohl 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.
PubMed 28302254Evered 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.
PubMed 21474666Mason 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.
PubMed 20858956Edipoglu 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.
PubMed 31561651Bekker A, Lee C, de Santi S, Pirraglia E, Zaslavsky A, Farber S, Haile M, de Leon MJ. Does mild cognitive impairment increase the risk of developing postoperative cognitive dysfunction? Am J Surg. 2010 Jun;199(6):782-8. doi: 10.1016/j.amjsurg.2009.07.042.
PubMed 20609722Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.
PubMed 25859906Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
PubMed 9525362Luo A, Yan J, Tang X, Zhao Y, Zhou B, Li S. Postoperative cognitive dysfunction in the aged: the collision of neuroinflammaging with perioperative neuroinflammation. Inflammopharmacology. 2019 Feb;27(1):27-37. doi: 10.1007/s10787-018-00559-0. Epub 2019 Jan 3.
PubMed 30607668Simen AA, Bordner KA, Martin MP, Moy LA, Barry LC. Cognitive dysfunction with aging and the role of inflammation. Ther Adv Chronic Dis. 2011 May;2(3):175-95. doi: 10.1177/2040622311399145.
PubMed 23251749Ortega-Gomez A, Perretti M, Soehnlein O. Resolution of inflammation: an integrated view. EMBO Mol Med. 2013 May;5(5):661-74. doi: 10.1002/emmm.201202382. Epub 2013 Apr 17.
PubMed 23592557
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation and Alzheimer's Pathology in Post-operative Cognitive Dysfunction: A Pilot Study
- ClinicalTrials.gov ID
- NCT05378659
- Acronym / sponsor ID
- POCD / 4790
- Keywords
- POCD, Neuroinflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- 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
- 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:
- 4 AT test for delirium
- Collect two 4ml blood samples will be taken
Visit 3 (Forty-eight hours after discharge):
- 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):
- Repeat cognitive testing
- 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:
- 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.
- Collect two 4-ml blood samples Visit 6 End of Study (At 6 months):
- Collect a final assessment of cognition
- ERP assessment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Post-Operative Cognitive Dysfunction | – | Behavioral: Montreal Cognitive Assessment, Behavioral: Stroop Test, Diagnostic Test: 4AT Delirium, Behavioral: Grooved Pegboard, Behavioral: NACC Cognitive Battery, Diagnostic Test: ERP Testing, Diagnostic Test: Blood Plasma and Serum sampling, Diagnostic Test: Cerebral Spinal Fluid SampleSubjects 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 |
| Without Post-Operative Cognitive Dysfunction | – | Behavioral: Montreal Cognitive Assessment, Behavioral: Stroop Test, Diagnostic Test: 4AT Delirium, Behavioral: Grooved Pegboard, Behavioral: NACC Cognitive Battery, Diagnostic Test: ERP Testing, Diagnostic Test: Blood Plasma and Serum sampling, Diagnostic Test: Cerebral Spinal Fluid SampleSubjects 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Males and females 60 years or older in age
- 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
Key exclusion criteria (5 listed)
- Less than 60 years of age
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montreal Cognitive AssessmentAlso: MOCACognitive evaluation of short term memory, visuospatial abilities, executive functioning, attention, concentration, working memory, language, and orientation to time and place | Behavioural | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
| Stroop TestEvaluates Processing Speed and Executive Control | Behavioural | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
| 4AT DeliriumScreening tool to test for delirium post surgery | Diagnostic test | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
| Grooved PegboardEvaluation testing for dominant and non dominant sensory-motor speed | Behavioural | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
| NACC Cognitive BatteryA series of tests that evaluate attention, concentration, immediate verbal memory, immediate visual memory, discrimination, processing/motor speed, and validity and effort. | Behavioural | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
| ERP TestingAn 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. | Diagnostic test | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
| Blood Plasma and Serum samplingUp to six 4 ml samples of both serum and plasma will be obtained to assess for inflammatory markers. | Diagnostic test | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
| Cerebral Spinal Fluid SampleAt the time the spinal is placed for anesthetic purposes, 2ml of cerebral spinal fluid will be obtained to assess for inflammatory markers. | Diagnostic test | With Post-Operative Cognitive Dysfunction, Without Post-Operative Cognitive Dysfunction |
Primary outcome
Blood Interleukin-1 beta (IL-1β)
Time frame: Baseline
A proinflammatory cytokine that activates astrocytes and micro ganglia
Blood Interleukin-1 beta (IL-1β)
Time frame: Pre-op (pre-operation) -Visit 2- Day of surgery
A proinflammatory cytokine that activates astrocytes and micro ganglia
Blood Interleukin-1 beta (IL-1β)
Time frame: Post-op Visit 2- In recovery room up to 12 hours post surgery
A proinflammatory cytokine that activates astrocytes and micro ganglia
Blood Interleukin-1 beta (IL-1β)
Time frame: 2 Week Post-op -Visit 4
A proinflammatory cytokine that activates astrocytes and micro ganglia
Blood Interleukin-1 beta (IL-1β)
Time frame: 6 Week Post-op -Visit 5
A proinflammatory cytokine that activates astrocytes and micro ganglia
Blood Tumor necrosis factor alpha (TNF- α)
Time frame: Baseline
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Blood Tumor necrosis factor alpha (TNF- α)
Time frame: Pre-op- Visit 2- Day of surgery
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Blood Tumor necrosis factor alpha (TNF- α)
Time frame: Post-op Visit 2- In recovery room up to 12 hours post surgery
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Blood Tumor necrosis factor alpha (TNF- α)
Time frame: 2-week Post-op Visit 4
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Blood Tumor necrosis factor alpha (TNF- α)
Time frame: 6-week Post-op Visit 5
A proinflammatory cytokine associated with neuroinflammation associated with neurodegenerative diseases
Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)
Time frame: Baseline
A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease
Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)
Time frame: Pre-op Visit 2- Day of surgery
A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease
Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)
Time frame: Post-op Visit 2- In recovery room up to 12 hours post surgery
A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease
Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)
Time frame: 2-week Post-op Visit 4
A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease
Blood Macrophage inflammatory protein-1 alpha (MIP-1alpha)
Time frame: 6- week Post-op Visit 5
A chemotactic cytokine which plays a role in the inflammatory process of Alzheimer's Disease
Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)
Time frame: Baseline
A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages
Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)
Time frame: Pre-op Visit 2- Day of surgery
A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages
Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)
Time frame: Post-op Visit 2- In recovery room up to 12 hours post surgery
A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages
Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)
Time frame: 2 week Post-op Visit 4
A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages
Blood Monocyte chemoattractant protein-1 (MCP-1/CCL2)
Time frame: 6 week- Post-op Visit 5
A chemotactic cytokine which plays a role in the inflammatory process through the regulation of monocytes/macrophages
Cerebral Spinal Fluid Phosphorylated Tau Protein
Time frame: Pre-op Visit 2-Day of surgery
A helical protein known to be a biomarker in the cerebral spinal fluid in brains with Alzheimer's Disease
ERP response amplitude
Time frame: 6 Week post-op visit 5
Measurement of event related potentials in the brain
ERP response latency
Time frame: 6 Week post-op visit 5
Measurement of event related potentials in the brain
ERP response amplitude
Time frame: 6 Month post-op visit 6
Measurement of event related potentials in the brain
ERP response latency
Time frame: 6 Month post-op visit 6
Measurement of event related potentials in the brain
Stroop Test
Time frame: Baseline
A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal."
Stroop Test
Time frame: Pre-op Visit 2- Day of surgery
A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal."
Stroop Test
Time frame: 2 Week post-op Visit 4
A neurocognitive test used to assess cognitive interference. T-Scores are computed with scores above 40 being "normal."
Montreal Cognitive Assessment
Time frame: Baseline
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.
Montreal Cognitive Assessment
Time frame: Pre-op Visit 2- Day of surgery
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.
Blind Montreal Cognitive Assessment
Time frame: 48 Hours post-op- Visit 3
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.
Montreal Cognitive Assessment
Time frame: 2 Week post-op- Visit 4
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.
Oral Trail Making Test
Time frame: Baseline
A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient.
Oral Trail Making Test
Time frame: Pre-op Visit 2- Day of surgery
A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient.
Oral Trail Making Test
Time frame: 48 Hours post-op Visit 3
A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient.
Oral Trail Making Test
Time frame: 2- Week post-op Visit 4
A neurocognitive test used to assess cognitive executive function with times for trail A > 78 seconds and trail B >273 seconds being deficient.
Symbol Digit Test
Time frame: Baseline
A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality.
Symbol Digit Test
Time frame: Pre-op Visit 2- Day of surgery
A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality.
Symbol Digit Test
Time frame: 2- Week post-op Visit 4
A neurocognitive test used to assess for cerebral dysfunction scored through statistical methods with a higher score meaning higher cognitive vitality.
4 AT Delirium Screening
Time frame: Post-op Visit 2- In recovery room up to 12 hours post surgery
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.
Grooved Pegboard Test
Time frame: 6 month post-op Visit 6
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.
National Alzheimer's Coordinating Center Cognitive Battery
Time frame: 6 month post-op Visit 6
Cognitive assessment to test for deficits across multiple domains with a score of 95/995 =physical problem; 96/996 = cognitive/behavioral problem
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 31166241Daiello 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.
- Background: PubMed 27537541O' 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.
- Background: PubMed 23371369Chen 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.
- Background: PubMed 28465805Pappa 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.
- Background: PubMed 31976614Xiao 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.
- Background: PubMed 28302254Feinkohl 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.
- Background: PubMed 21474666Evered 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.
- Background: PubMed 20858956Mason 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.
- Background: PubMed 31561651Edipoglu 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.
- Background: PubMed 20609722Bekker A, Lee C, de Santi S, Pirraglia E, Zaslavsky A, Farber S, Haile M, de Leon MJ. Does mild cognitive impairment increase the risk of developing postoperative cognitive dysfunction? Am J Surg. 2010 Jun;199(6):782-8. doi: 10.1016/j.amjsurg.2009.07.042.
- Background: PubMed 25859906Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.
- Background: PubMed 9525362Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Craft, MD principal investigator
University of Tennessee Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Operative Confusion and Neuroinflammatory Response, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Department of Anesthesiology Chair (8653059220, rcraft@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Interleukin-1 beta (IL-1β) (time frame: Baseline). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378659, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.