Dementia Clinical Trial
— POCD-MRIOfficial title:
Association Between Changes in Cerebral Gray Matter Volume and Postoperative Cognitive Dysfunction in Elderly Patients Following Sevoflurane Anesthesia (POCD-MRI)
NCT number | NCT02045004 |
Other study ID # | POCD-MRI |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 14, 2015 |
Est. completion date | November 2018 |
Verified date | November 2018 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Despite an ongoing controversy in the scientific literature, the link between anesthesia and
dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an
association of surgery with a reduction in brain volume. With the present prospective cohort
study, we would like to reproduce and verify these results, and investigate a possible
association with the postoperative cognitive performance.
We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months
after major non-cardiac surgery and determine cognitive functions at the same time.
Study hypothesis:
1. Surgery under general anesthesia in elderly patients is associated with a loss of gray
matter.
2. The degree of cognitive dysfunction is associated with the loss of grey matter in brain
areas relevant for cognitive functions.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Age = 65 years - Elective major surgery - Planned general anesthesia Exclusion Criteria: - Cardiac surgery - Neurosurgery including carotid endarterectomy - Preoperative Mini Mental State (MMS) Examination Score < 24 - Previous pathological neuroimaging (if available) - History of cerebral or cerebrovascular pathology - Chronic use of psychiatric medication - Alcohol or substance abuse - A history of chronic pain unrelated to the planned surgery - Any contraindication for MRI (e.g. pacemakers and other MR-incompatible metal implants) - Claustrophobia - Lack of informed consent |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
Nicolai Goettel | University Hospital, Basel, Switzerland |
Switzerland,
Avidan MS, Searleman AC, Storandt M, Barnett K, Vannucci A, Saager L, Xiong C, Grant EA, Kaiser D, Morris JC, Evers AS. Long-term cognitive decline in older subjects was not attributable to noncardiac surgery or major illness. Anesthesiology. 2009 Nov;111(5):964-70. doi: 10.1097/ALN.0b013e3181bc9719. — View Citation
Baranov D, Bickler PE, Crosby GJ, Culley DJ, Eckenhoff MF, Eckenhoff RG, Hogan KJ, Jevtovic-Todorovic V, Palotás A, Perouansky M, Planel E, Silverstein JH, Wei H, Whittington RA, Xie Z, Zuo Z; First International Workshop on Anesthetics and Alzheimer's Disease. Consensus statement: First International Workshop on Anesthetics and Alzheimer's disease. Anesth Analg. 2009 May;108(5):1627-30. doi: 10.1213/ane.0b013e318199dc72. — View Citation
Burkhart CS, Birkner-Binder D, Gagneux A, Berres M, Strebel SP, Monsch AU, Steiner LA. Evaluation of a summary score of cognitive performance for use in trials in perioperative and critical care. Dement Geriatr Cogn Disord. 2011;31(6):451-9. doi: 10.1159/000329442. Epub 2011 Jul 20. — View Citation
Burkhart CS, Steiner LA. Can postoperative cognitive dysfunction be avoided? Hosp Pract (1995). 2012 Feb;40(1):214-23. doi: 10.3810/hp.2012.02.962. — View Citation
Cerejeira J, Firmino H, Vaz-Serra A, Mukaetova-Ladinska EB. The neuroinflammatory hypothesis of delirium. Acta Neuropathol. 2010 Jun;119(6):737-54. doi: 10.1007/s00401-010-0674-1. Epub 2010 Mar 24. Review. — View Citation
Chandler MJ, Lacritz LH, Hynan LS, Barnard HD, Allen G, Deschner M, Weiner MF, Cullum CM. A total score for the CERAD neuropsychological battery. Neurology. 2005 Jul 12;65(1):102-6. — View Citation
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation
Culley DJ, Baxter MG, Crosby CA, Yukhananov R, Crosby G. Impaired acquisition of spatial memory 2 weeks after isoflurane and isoflurane-nitrous oxide anesthesia in aged rats. Anesth Analg. 2004 Nov;99(5):1393-7; table of contents. — View Citation
Eckenhoff RG, Johansson JS, Wei H, Carnini A, Kang B, Wei W, Pidikiti R, Keller JM, Eckenhoff MF. Inhaled anesthetic enhancement of amyloid-beta oligomerization and cytotoxicity. Anesthesiology. 2004 Sep;101(3):703-9. — View Citation
Ehrensperger MM, Berres M, Taylor KI, Monsch AU. Early detection of Alzheimer's disease with a total score of the German CERAD. J Int Neuropsychol Soc. 2010 Sep;16(5):910-20. doi: 10.1017/S1355617710000822. Epub 2010 Aug 4. — View Citation
Helms G, Draganski B, Frackowiak R, Ashburner J, Weiskopf N. Improved segmentation of deep brain grey matter structures using magnetization transfer (MT) parameter maps. Neuroimage. 2009 Aug 1;47(1):194-8. doi: 10.1016/j.neuroimage.2009.03.053. Epub 2009 Mar 31. — View Citation
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation
Kherif F, Poline JB, Flandin G, Benali H, Simon O, Dehaene S, Worsley KJ. Multivariate model specification for fMRI data. Neuroimage. 2002 Aug;16(4):1068-83. — View Citation
Kline RP, Pirraglia E, Cheng H, De Santi S, Li Y, Haile M, de Leon MJ, Bekker A; Alzheimer's Disease Neuroimaging Initiative. Surgery and brain atrophy in cognitively normal elderly subjects and subjects diagnosed with mild cognitive impairment. Anesthesiology. 2012 Mar;116(3):603-12. doi: 10.1097/ALN.0b013e318246ec0b. — View Citation
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. — View Citation
Liu Y, Paajanen T, Zhang Y, Westman E, Wahlund LO, Simmons A, Tunnard C, Sobow T, Mecocci P, Tsolaki M, Vellas B, Muehlboeck S, Evans A, Spenger C, Lovestone S, Soininen H; AddNeuroMed Consortium. Combination analysis of neuropsychological tests and structural MRI measures in differentiating AD, MCI and control groups--the AddNeuroMed study. Neurobiol Aging. 2011 Jul;32(7):1198-206. doi: 10.1016/j.neurobiolaging.2009.07.008. Epub 2009 Aug 14. — View Citation
Mapleson WW. Effect of age on MAC in humans: a meta-analysis. Br J Anaesth. 1996 Feb;76(2):179-85. — View Citation
McHorney CA. Measuring and monitoring general health status in elderly persons: practical and methodological issues in using the SF-36 Health Survey. Gerontologist. 1996 Oct;36(5):571-83. Review. — View Citation
Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. — View Citation
Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. — View Citation
Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. Review. — View Citation
Seitz DP, Shah PS, Herrmann N, Beyene J, Siddiqui N. Exposure to general anesthesia and risk of Alzheimer's disease: a systematic review and meta-analysis. BMC Geriatr. 2011 Dec 14;11:83. doi: 10.1186/1471-2318-11-83. Review. — View Citation
Smielewski P, Czosnyka M, Steiner L, Belestri M, Piechnik S, Pickard JD. ICM+: software for on-line analysis of bedside monitoring data after severe head trauma. Acta Neurochir Suppl. 2005;95:43-9. — View Citation
Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569. — View Citation
Steinmetz J, Siersma V, Kessing LV, Rasmussen LS; ISPOCD Group. Is postoperative cognitive dysfunction a risk factor for dementia? A cohort follow-up study. Br J Anaesth. 2013 Jun;110 Suppl 1:i92-7. doi: 10.1093/bja/aes466. Epub 2012 Dec 28. — View Citation
Terrando N, Monaco C, Ma D, Foxwell BM, Feldmann M, Maze M. Tumor necrosis factor-alpha triggers a cytokine cascade yielding postoperative cognitive decline. Proc Natl Acad Sci U S A. 2010 Nov 23;107(47):20518-22. doi: 10.1073/pnas.1014557107. Epub 2010 Nov 1. — View Citation
van Gool WA, van de Beek D, Eikelenboom P. Systemic infection and delirium: when cytokines and acetylcholine collide. Lancet. 2010 Feb 27;375(9716):773-5. doi: 10.1016/S0140-6736(09)61158-2. — View Citation
Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. — View Citation
Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013. — View Citation
Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral gray matter volume | Hippocampal volume is specifically assessed. | Preoperatively, at 3 month and 12 month postoperatively | |
Secondary | Cognitive function | The neuropsychological assessment test battery CERAD-Plus consistent of the Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB), Trail Making Tests A+B, and phonetic fluency (s-words), as well as the Test for Attentional Performance (TAP) developed to analyze different aspects of attention, will be performed. Cognitive functions will be quantified using the CERAD total score, in its demographically corrected form. | Preoperatively, at 7 days, 3 month and 12 month postoperatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05686486 -
Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
|
N/A | |
Terminated |
NCT05451693 -
Outreach-ER: A Dementia Care Intervention Program
|
||
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Enrolling by invitation |
NCT06040294 -
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
|
N/A | |
Completed |
NCT05114187 -
An Internet-Based Education Program for Care Partners of People Living With Dementia
|
N/A | |
Recruiting |
NCT06322121 -
Vascular Aspects in Dementia: Part 2
|
||
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Recruiting |
NCT03462485 -
Pilot Study of the Effects of Playing Golf on People With Dementia
|
N/A | |
Active, not recruiting |
NCT03677284 -
Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia
|
N/A | |
Completed |
NCT03849937 -
Changing Talk Online (CHATO) Study
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Completed |
NCT04571697 -
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Recruiting |
NCT06033066 -
Financial Incentives and Recruitment to the APT Webstudy
|
N/A | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT05684783 -
Dementia Champions in Homecare
|
||
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A |