Hepatic EncephalopathyNCT02083367
Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome
An observational study of Hepatic Encephalopathy and Cirrhosis, run by OSF Healthcare System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis, Nonalcoholic Steatohepatitis
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Hospital Gastroenterology Clinic.
Who may be able to join
- 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)
Show all 10Show fewer
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
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.
Read the detailed description
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.
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis, Non-alcoholic Fatty Liver Disease, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Encephalopathy Group | Disease Group | |
| Control Group | Healthy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MRI imagining
4 Paradigms:
- Resting
- Tactile Touch
- Motor
- Auditory
Measured: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Secondary outcomes (4)
EEG Testing
Measured: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Neuropsychological Testing
WAIS-III PHES Digit Span and Trails
Measured: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Neurological Examination
Measured: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Serum Ammonia Level
Hepatic Encephalopathy Group only
Measured: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niral Patel, OSF Healthcare System
- Investigators
- Nisha Bhatia, MD, Principal investigator, OSF Healthcare SystemHrachya Nersesyan, MD, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083367
- Sponsor's protocol ID
- OSF-14-001
- Status last verified
- May 2015
- First submitted
- 5 Mar 2014
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16186014Bluhm 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.
PubMed 18463507Boly 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.
PubMed 18591474Boly 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.
PubMed 19350563Buckner 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.
PubMed 18400922Calhoun 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.
PubMed 11559959Cauda 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.
PubMed 19289479Coleman 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.
PubMed 1971018210. 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.
PubMed 18975482Garrity 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.
PubMed 17329470Gofton 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.
PubMed 19306870Greicius 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.
PubMed 18219620Greicius 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.
PubMed 12506194Greicius M. Resting-state functional connectivity in neuropsychiatric disorders. Curr Opin Neurol. 2008 Aug;21(4):424-30. doi: 10.1097/WCO.0b013e328306f2c5.
PubMed 18607202
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Default Mode Network fMRI Maps as a Predictive Index of Hepatic Encephalopathy Outcome
- ClinicalTrials.gov ID
- NCT02083367
- Acronym / sponsor ID
- OSF-14-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatic Encephalopathy Group | – | –Disease Group |
| Control Group | – | –Healthy Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Hospital Gastroenterology Clinic.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional MRI imagining
Time frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
4 Paradigms: 1. Resting 2. Tactile Touch 3. Motor 4. Auditory
4 secondary outcomes
EEG Testing
Time frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Neuropsychological Testing
Time frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Neurological Examination
Time frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Serum Ammonia Level
Time frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Background: PubMed 16186014Baars 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.
- Background: PubMed 18463507Bluhm 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.
- Background: PubMed 18591474Boly 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.
- Background: PubMed 19350563Boly 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.
- Background: PubMed 18400922Buckner 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.
- Background: PubMed 11559959Calhoun 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.
- Background: PubMed 19289479Cauda 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.
- Background: PubMed 19710182Coleman 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.
- Background10. Coma. New York: Oxford University Press; 2007.
- Background: PubMed 18975482Di 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.
- Background: PubMed 17329470Garrity 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.
- Background: PubMed 19306870Gofton 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.
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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.
Nisha Bhatia, MD principal investigator
OSF Healthcare System
Hrachya Nersesyan, MD principal investigator
OSF Healthcare System
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 Hepatic Encephalopathy and Cirrhosis, run by OSF Healthcare System 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 25 May 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MRI imagining (time frame: Participants will be followed until all study assessments have been completed, an expected average 4 weeks.). 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 NCT02083367, which also lists 30 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 25 May 2015; AzTrials last refreshed its copy on 27 Oct 2026.