Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT02083367
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional MRI imagining', 'timeFrame': 'Participants will be followed until all study assessments have been completed, an expected average 4 weeks.', 'description': '4 Paradigms:\n\n1. Resting\n2. Tactile Touch\n3. Motor\n4. Auditory'}], 'secondaryOutcomes': [{'measure': 'EEG Testing', 'timeFrame': 'Participants will be followed until all study assessments have been completed, an expected average 4 weeks.'}, {'measure': 'Neuropsychological Testing', 'timeFrame': 'Participants will be followed until all study assessments have been completed, an expected average 4 weeks.', 'description': 'WAIS-III PHES Digit Span and Trails'}, {'measure': 'Neurological Examination', 'timeFrame': 'Participants will be followed until all study assessments have been completed, an expected average 4 weeks.'}, {'measure': 'Serum Ammonia Level', 'timeFrame': 'Participants will be followed until all study assessments have been completed, an expected average 4 weeks.', 'description': 'Hepatic Encephalopathy Group only'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy', 'Cirrhosis', 'Nonalcoholic Steatohepatitis', 'Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '16186014', 'type': 'BACKGROUND', 'citation': 'Baars BJ. Global workspace theory of consciousness: toward a cognitive neuroscience of human experience. Prog Brain Res. 2005;150:45-53. doi: 10.1016/S0079-6123(05)50004-9.'}, {'pmid': '18463507', 'type': 'BACKGROUND', 'citation': 'Bluhm RL, Osuch EA, Lanius RA, Boksman K, Neufeld RW, Theberge J, Williamson P. Default mode network connectivity: effects of age, sex, and analytic approach. Neuroreport. 2008 May 28;19(8):887-91. doi: 10.1097/WNR.0b013e328300ebbf.'}, {'pmid': '18591474', 'type': 'BACKGROUND', 'citation': 'Boly M, Phillips C, Tshibanda L, Vanhaudenhuyse A, Schabus M, Dang-Vu TT, Moonen G, Hustinx R, Maquet P, Laureys S. Intrinsic brain activity in altered states of consciousness: how conscious is the default mode of brain function? Ann N Y Acad Sci. 2008;1129:119-29. doi: 10.1196/annals.1417.015.'}, {'pmid': '19350563', 'type': 'BACKGROUND', 'citation': 'Boly M, Tshibanda L, Vanhaudenhuyse A, Noirhomme Q, Schnakers C, Ledoux D, Boveroux P, Garweg C, Lambermont B, Phillips C, Luxen A, Moonen G, Bassetti C, Maquet P, Laureys S. Functional connectivity in the default network during resting state is preserved in a vegetative but not in a brain dead patient. Hum Brain Mapp. 2009 Aug;30(8):2393-400. doi: 10.1002/hbm.20672.'}, {'pmid': '18400922', 'type': 'BACKGROUND', 'citation': "Buckner RL, Andrews-Hanna JR, Schacter DL. The brain's default network: anatomy, function, and relevance to disease. Ann N Y Acad Sci. 2008 Mar;1124:1-38. doi: 10.1196/annals.1440.011."}, {'pmid': '11559959', 'type': 'BACKGROUND', 'citation': 'Calhoun VD, Adali T, Pearlson GD, Pekar JJ. A method for making group inferences from functional MRI data using independent component analysis. Hum Brain Mapp. 2001 Nov;14(3):140-51. doi: 10.1002/hbm.1048.'}, {'pmid': '19289479', 'type': 'BACKGROUND', 'citation': "Cauda F, Micon BM, Sacco K, Duca S, D'Agata F, Geminiani G, Canavero S. Disrupted intrinsic functional connectivity in the vegetative state. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):429-31. doi: 10.1136/jnnp.2007.142349."}, {'pmid': '19710182', 'type': 'BACKGROUND', 'citation': 'Coleman MR, Davis MH, Rodd JM, Robson T, Ali A, Owen AM, Pickard JD. Towards the routine use of brain imaging to aid the clinical diagnosis of disorders of consciousness. Brain. 2009 Sep;132(Pt 9):2541-52. doi: 10.1093/brain/awp183.'}, {'type': 'BACKGROUND', 'citation': '10. Coma. New York: Oxford University Press; 2007.'}, {'pmid': '18975482', 'type': 'BACKGROUND', 'citation': 'Di H, Boly M, Weng X, Ledoux D, Laureys S. Neuroimaging activation studies in the vegetative state: predictors of recovery? Clin Med (Lond). 2008 Oct;8(5):502-7. doi: 10.7861/clinmedicine.8-5-502.'}, {'pmid': '17329470', 'type': 'BACKGROUND', 'citation': 'Garrity AG, Pearlson GD, McKiernan K, Lloyd D, Kiehl KA, Calhoun VD. Aberrant "default mode" functional connectivity in schizophrenia. Am J Psychiatry. 2007 Mar;164(3):450-7. doi: 10.1176/ajp.2007.164.3.450.'}, {'pmid': '19306870', 'type': 'BACKGROUND', 'citation': 'Gofton TE, Chouinard PA, Young GB, Bihari F, Nicolle MW, Lee DH, Sharpe MD, Yen YF, Takahashi AM, Mirsattari SM. Functional MRI study of the primary somatosensory cortex in comatose survivors of cardiac arrest. Exp Neurol. 2009 Jun;217(2):320-7. doi: 10.1016/j.expneurol.2009.03.011. Epub 2009 Mar 21.'}, {'pmid': '18219620', 'type': 'BACKGROUND', 'citation': 'Greicius MD, Kiviniemi V, Tervonen O, Vainionpaa V, Alahuhta S, Reiss AL, Menon V. Persistent default-mode network connectivity during light sedation. Hum Brain Mapp. 2008 Jul;29(7):839-47. doi: 10.1002/hbm.20537.'}, {'pmid': '12506194', 'type': 'BACKGROUND', 'citation': 'Greicius MD, Krasnow B, Reiss AL, Menon V. Functional connectivity in the resting brain: a network analysis of the default mode hypothesis. Proc Natl Acad Sci U S A. 2003 Jan 7;100(1):253-8. doi: 10.1073/pnas.0135058100. Epub 2002 Dec 27.'}, {'pmid': '18607202', 'type': 'BACKGROUND', 'citation': 'Greicius M. Resting-state functional connectivity in neuropsychiatric disorders. Curr Opin Neurol. 2008 Aug;21(4):424-30. doi: 10.1097/WCO.0b013e328306f2c5.'}, {'pmid': '46957', 'type': 'BACKGROUND', 'citation': 'Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet. 1975 Mar 1;1(7905):480-4. doi: 10.1016/s0140-6736(75)92830-5.'}, {'pmid': '17679641', 'type': 'BACKGROUND', 'citation': 'Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.'}, {'pmid': '16823480', 'type': 'BACKGROUND', 'citation': 'Laureys S, Boly M, Maquet P. Tracking the recovery of consciousness from coma. J Clin Invest. 2006 Jul;116(7):1823-5. doi: 10.1172/JCI29172.'}, {'pmid': '17234951', 'type': 'BACKGROUND', 'citation': 'Mason MF, Norton MI, Van Horn JD, Wegner DM, Grafton ST, Macrae CN. Wandering minds: the default network and stimulus-independent thought. Science. 2007 Jan 19;315(5810):393-5. doi: 10.1126/science.1131295.'}, {'type': 'BACKGROUND', 'citation': "McKiernan KA, D'Angelo BR, Kaufman JN, Binder JR. Interrupting the"}, {'pmid': '15356426', 'type': 'BACKGROUND', 'citation': 'Nersesyan H, Herman P, Erdogan E, Hyder F, Blumenfeld H. Relative changes in cerebral blood flow and neuronal activity in local microdomains during generalized seizures. J Cereb Blood Flow Metab. 2004 Sep;24(9):1057-68. doi: 10.1097/01.WCB.0000131669.02027.3E.'}, {'pmid': '22218274', 'type': 'BACKGROUND', 'citation': 'Norton L, Hutchison RM, Young GB, Lee DH, Sharpe MD, Mirsattari SM. Disruptions of functional connectivity in the default mode network of comatose patients. Neurology. 2012 Jan 17;78(3):175-81. doi: 10.1212/WNL.0b013e31823fcd61. Epub 2012 Jan 4.'}, {'pmid': '11209064', 'type': 'BACKGROUND', 'citation': 'Raichle ME, MacLeod AM, Snyder AZ, Powers WJ, Gusnard DA, Shulman GL. A default mode of brain function. Proc Natl Acad Sci U S A. 2001 Jan 16;98(2):676-82. doi: 10.1073/pnas.98.2.676.'}, {'pmid': '17719799', 'type': 'BACKGROUND', 'citation': 'Raichle ME, Snyder AZ. A default mode of brain function: a brief history of an evolving idea. Neuroimage. 2007 Oct 1;37(4):1083-90; discussion 1097-9. doi: 10.1016/j.neuroimage.2007.02.041. Epub 2007 Mar 6.'}, {'pmid': '19862509', 'type': 'BACKGROUND', 'citation': 'Tshibanda L, Vanhaudenhuyse A, Boly M, Soddu A, Bruno MA, Moonen G, Laureys S, Noirhomme Q. Neuroimaging after coma. Neuroradiology. 2010 Jan;52(1):15-24. doi: 10.1007/s00234-009-0614-8.'}, {'pmid': '20034928', 'type': 'BACKGROUND', 'citation': 'Vanhaudenhuyse A, Noirhomme Q, Tshibanda LJ, Bruno MA, Boveroux P, Schnakers C, Soddu A, Perlbarg V, Ledoux D, Brichant JF, Moonen G, Maquet P, Greicius MD, Laureys S, Boly M. Default network connectivity reflects the level of consciousness in non-communicative brain-damaged patients. Brain. 2010 Jan;133(Pt 1):161-71. doi: 10.1093/brain/awp313. Epub 2009 Dec 23.'}, {'pmid': '17476267', 'type': 'BACKGROUND', 'citation': 'Vincent JL, Patel GH, Fox MD, Snyder AZ, Baker JT, Van Essen DC, Zempel JM, Snyder LH, Corbetta M, Raichle ME. Intrinsic functional architecture in the anaesthetized monkey brain. Nature. 2007 May 3;447(7140):83-6. doi: 10.1038/nature05758.'}, {'type': 'BACKGROUND', 'citation': '29. Weissenborn, Karin, et al.'}, {'pmid': '16864809', 'type': 'BACKGROUND', 'citation': 'Wijdicks EF, Hijdra A, Young GB, Bassetti CL, Wiebe S; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter: prediction of outcome in comatose survivors after cardiopulmonary resuscitation (an evidence-based review) [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006 Jul 25;67(2):203-10. doi: 10.1212/01.wnl.0000227183.21314.cd.'}, {'pmid': '19657124', 'type': 'BACKGROUND', 'citation': 'Young GB. Clinical practice. Neurologic prognosis after cardiac arrest. N Engl J Med. 2009 Aug 6;361(6):605-11. doi: 10.1056/NEJMcp0903466. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Investigating the impact of hepatic encephalopathy on default mode networks within the brain to provide more clues with understanding the physiology of consciousness and predicting the reversibility of comatose states.', 'detailedDescription': 'The proposed study will provide better understanding of the patterns of default mode network (DMN) dysfunction in comatose state of hepatic encephalopathy, may help to further define the boundaries of neuronal circuits involve, and will try to assess the prognostic value of fMRI in reversibility of severe metabolic coma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community Hospital Gastroenterology Clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': "(Hepatic Encephalopathy Group)\n\nInclusion Criteria:\n\n* Patient or legally acceptable representative must understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.\n* Age 18 or older at the time of informed consent.\n* Patients with liver cirrhosis attending the gastroenterology department (inpatient or outpatient) with hepatic encephalopathy from various causes of liver failure (i.e. alcoholic, infectious, carcinomatous or toxic).\n* The patients will be selected applying Child Pughs score and West Raven classification for hepatic encephalopathy.\n* All patients participating in the study will undergo a full neurological exam, 30 min routine EEG recording and neuropsychological evaluation along with the f-MRI study.\n\n(Hepatic Encephalopathy Group)\n\nExclusion Criteria:\n\n* History of alcohol consumption or illicit drug use within past 3 months.\n* Patients with underlying psychiatric or neurologic illness (i.e. schizophrenia, untreated major depressive disorder, epilepsy, neurodegenerative dementia, etc.) resulting in unrelated to encephalopathy impairment of consciousness and/or alteration of normal mental capacity.\n* Patients after head injury or with advanced pulmonary, renal, or other than liver failure metabolic disorder (such as severe hypoxia, hypo/hyperglycemia, metabolic acidosis or alkalosis).\n* Patients requiring sedation for MRI.\n* Pregnant women.\n\n(Normal Control Group)\n\nInclusion Criteria:\n\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.\n* Be age 18 or older at the time of informed consent.\n* Subjects must be right handed, be free from any neurological injury, be free from any neurological diseases, be free from any psychological diseases, have a baseline Blood pressure \\< 140/90, not currently be taking any mind altering medications (including antidepressants, anxiolytics, or opioid/narcotic pain medications), and not have claustrophobia\n\n(Normal Control Group)\n\nExclusion Criteria:\n\n* Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.\n* History of alcohol consumption 1 week prior to the MRI.\n* Illicit drug use within past 3 months.\n* Patients requiring sedation for MRI.\n* Pregnant women.\n* Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study."}, 'identificationModule': {'nctId': 'NCT02083367', 'briefTitle': 'Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome', 'organization': {'class': 'OTHER', 'fullName': 'OSF Healthcare System'}, 'officialTitle': 'Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome', 'orgStudyIdInfo': {'id': 'OSF-14-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatic Encephalopathy Group', 'description': 'Disease Group'}, {'label': 'Control Group', 'description': 'Healthy Group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF Saint Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}], 'overallOfficials': [{'name': 'Nisha Bhatia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSF Healthcare System'}, {'name': 'Hrachya Nersesyan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSF Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OSF Healthcare System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Niral Patel', 'investigatorAffiliation': 'OSF Healthcare System'}}}}