- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02083367
Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome
21 de mayo de 2015 actualizado por: Niral Patel, OSF Healthcare System
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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
12
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Illinois
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Peoria, Illinois, Estados Unidos, 61637
- OSF Saint Francis Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Community Hospital Gastroenterology Clinic.
Descripción
(Hepatic Encephalopathy Group)
Inclusion Criteria:
- 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.
- Age 18 or older at the time of informed consent.
- 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).
- The patients will be selected applying Child Pughs score and West Raven classification for hepatic encephalopathy.
- 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.
(Hepatic Encephalopathy Group)
Exclusion Criteria:
- History of alcohol consumption or illicit drug use within past 3 months.
- 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.
- 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).
- Patients requiring sedation for MRI.
- Pregnant women.
(Normal Control Group)
Inclusion Criteria:
- 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.
- Be age 18 or older at the time of informed consent.
- 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
(Normal Control Group)
Exclusion Criteria:
- 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.
- History of alcohol consumption 1 week prior to the MRI.
- Illicit drug use within past 3 months.
- Patients requiring sedation for MRI.
- Pregnant women.
- Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Hepatic Encephalopathy Group
Disease Group
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Control Group
Healthy Group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Functional MRI imagining
Periodo de tiempo: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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4 Paradigms:
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Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
EEG Testing
Periodo de tiempo: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Neuropsychological Testing
Periodo de tiempo: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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WAIS-III PHES Digit Span and Trails
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Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Neurological Examination
Periodo de tiempo: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Serum Ammonia Level
Periodo de tiempo: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Hepatic Encephalopathy Group only
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Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nisha Bhatia, MD, OSF HealthCare System
- Investigador principal: Hrachya Nersesyan, MD, OSF HealthCare System
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Hum Brain Mapp 2002 Jun;16(2):131.
- 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.
- 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.
- 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.
- 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): 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 10. Coma. New York: Oxford University Press; 2007.
- 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.
- Garrity AG, Pearlson GD, McKiernan K, Lloyd D, Kiehl KA, Calhoun VD. Aberrant
- 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.
- 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.
- Greicius M. Resting-state functional connectivity in neuropsychiatric disorders. Curr Opin Neurol. 2008 Aug;21(4):424-30. doi: 10.1097/WCO.0b013e328306f2c5.
- 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.
- 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.
- McKiernan KA, D'Angelo BR, Kaufman JN, Binder JR. Interrupting the "stream of consciousness": an fMRI investigation. Neuroimage. 2006 Feb 15;29(4):1185-91. doi: 10.1016/j.neuroimage.2005.09.030. Epub 2005 Nov 2.
- 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.
- 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.
- 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.
- 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.
- 29. Weissenborn, Karin, et al.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2013
Finalización primaria (Actual)
1 de octubre de 2014
Finalización del estudio (Actual)
1 de febrero de 2015
Fechas de registro del estudio
Enviado por primera vez
5 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
6 de marzo de 2014
Publicado por primera vez (Estimar)
11 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
25 de mayo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
21 de mayo de 2015
Última verificación
1 de mayo de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Insuficiencia hepática
- Insuficiencia hepática
- Enfermedades metabólicas
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Enfermedades Cerebrales Metabólicas
- Hepatitis
- Hepatitis C
- Hígado graso
- Enfermedad del hígado graso no alcohólico
- Encefalopatía hepática
- Enfermedades Cerebrales
Otros números de identificación del estudio
- OSF-14-001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .