Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 5:20 AM
Study NCT ID:
NCT06619106
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-09-26', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity and specificity of the construction test according to the diagnosis of MHE, after construction of a logistic model.', 'timeFrame': 'between day 0 and 14 from inclusion'}], 'secondaryOutcomes': [{'measure': 'Comparison of the sensitivities and specificities of the construction test compared to the MHE reference tests', 'timeFrame': 'Between day 0 and 14 from inclusion', 'description': 'Comparison of the sensitivities and specificities of the construction test compared to the MHE reference tests like: PHES (Psychometric Hepatic Encephalopathy Score), CFF (Critical Flicker Frequency test), ANT (Animal Naming Test)'}, {'measure': 'Evaluate the sensitivity and specificity of the construction test for the diagnosis of hepatic encephalopathy, taking into account the presence of neurological comorbidities.', 'timeFrame': 'Between day 0 and 14 from inclusion'}, {'measure': 'Correlation analysis between subsets of the construction test (planning, speed, selective attention, memory) with reference cognitive tests assessing these cognitive functions', 'timeFrame': 'Between day 0 and 14 from inclusion', 'description': 'Correlation analysis between subsets of the construction test (planning, speed, selective attention, memory) with reference cognitive tests assessing these cognitive functions like: ROCF (Rey-Osterrieth complex figure), FCSRT (Free and Cued Selective Reminding test), MCT (Mesulam cancelling task), PHES subtests (Psychometric Hepatic Encephalopathy Score)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic encephalopathy', 'hepatic failure', 'neuropsychology', 'neurology', 'cognitive tools'], 'conditions': ['Hepatic Pathology (Fibrosis, Cirrhosis, Porto Systemic Shunts)']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to evaluate the sensitivity and specificity of a cognitive test toward the presence of minimal hepatic encephalopathy (MHE). MHE is a neurological complication due to hepatic dysfunction and/or the presence of porto-systemic shunts defined by the presence of neurocognitive impairments (NI). Other factors of brain injury may cause NI independently from the liver condition making the differential diagnosis difficult using available cognitive tests (ANT Animal Naming Test, PHES Psychometric Hepatic Encephalopathy Score, CFF Critical Flicker Frequency test). The cognitive test evaluated in this project is a construction task using construction blocks, allowing the evaluation of psychomotor speed, executive functions, attention, and episodic memory. The measures will be compared to other cognitive tests validated for the evaluation of the targeted cognitive functions (PHES, Mesulam Cancelling task, Rey-Osterrieth complex figure, Free and Cued Selective Reminding Test) and cognitive tests validated for the diagnosis of MHE (PHES, ANT, CFF). The diagnosis of MHE is based on an adjudication committee including a multimodal assessment of MHE (brain MRI with spectroscopy, EEG, blood sample, neuropsychological assessment), allowing the evaluation of comorbidities such as other factors of brain injury.', 'detailedDescription': 'Hepatic encephalopathy (HE), corresponding to all the neurocognitive symptoms caused by liver damage and/or the presence of portosystemic shunts. HE can take several forms depending on its intensity, ranging from subtle neuropsychological abnormalities that are difficult to detect during a routine interview ("minimal" HE, MHE) to temporospatial disorientation and confusion that can lead to coma ( "overt" HE, OHE). MHE can significantly impair the quality of life of patients and caregivers; it is associated with a poorer prognosis of liver pathology and a significantly more frequent occurrence of OHE. Detection of MHE is complex, and involves the convergence of a large number of tests recognized as sensitive: venous ammonia level, electroencephalogram, MRI with spectroscopy, complete neuropsychological assessment. Today, there is no unanimously recognized Gold Standard.\n\nThe objective of this research project is to develop a cognitive test to detect HE sensitively and specifically, in order to detect HE.\n\nTo do this, the investigators will evaluate the qualities of a rapid and accessible test. It is a test made up of building blocks to assess psychomotor speed, attention, executive functions and episodic memory. If it proves sensitive and specific enough for the diagnosis of MHE, it could be disseminated and allow the screening of MHE.\n\nTo do this, the investigators will compare the block construction test to other neuropsychological examinations validated in the diagnosis of MHE (PHES: Psychometric Hepatic Encephalopathy Score, CFF: Critical Flicker Frequency test, ANT: Animal Naming Test). These examinations are reference cognitive tests in the diagnosis of MHE, but the results between these tests diverge and do not currently make it possible to replace all of the clinical examinations described above. The investigators will also compare the construction block test to cognitive tests validated for the evaluation of the targeted cognitive functions (ROCF Rey-Osterrieth complex figure, FCSRT Free and Cued Selective Reminding test, MCT Mesulam cancelling task). The diagnosis of MHE is based on an adjudication committee including a multimodal assessment of MHE (brain MRI with spectroscopy, EEG, blood sample, neuropsychological assessment), allowing the evaluation of comorbidities such as other factors of brain injury.\n\nMain objective : to evaluate the sensitivity and specificity of the construction test to the presence of MHE.\n\nSecondary objectives:\n\n1. Comparison of screening qualities of the construction test to MHE diagnosis validated tests (PHES, CFF, ANT)\n2. Evaluate the impact of the presence of comorbidities (factors of brain injury) in the results of the construction test.\n3. Evaluate the psychometric qualities of the construction test compared to validated neuropsychological tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with liver cirrhosis or portosystemic shunts with suspicion of minimal hepatic encephalopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Hepatic pathology (fibrosis, cirrhosis, porto-systemic shunts)\n* Evaluation at BLIPS clinic (neuropsychological assessment, MRI, EEG and blood sample with ammonia)\n\nExclusion Criteria:\n\n* Opposition to participating in the study\n* Not being affiliated with French healthcare system'}, 'identificationModule': {'nctId': 'NCT06619106', 'acronym': 'BLOCK-HE', 'briefTitle': 'Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy: Pilot Study', 'orgStudyIdInfo': {'id': 'APHP231310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Population with chronic liver disease or the presence of portal-systemic shunts, attending the BLIPS day hospital', 'interventionNames': ['Other: Cognitive test']}], 'interventions': [{'name': 'Cognitive test', 'type': 'OTHER', 'description': 'Cognitive test based on building blocks', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lyès KHELOUFI', 'role': 'CONTACT', 'email': 'lyes.kheloufi@aphp.fr', 'phone': '01 84 82 74 83', 'phoneExt': '+33'}, {'name': 'Nicolas WEISS, MD,PhD', 'role': 'CONTACT', 'email': 'nicolas.weiss@aphp.fr', 'phone': '01 42 16 27 70', 'phoneExt': '+33'}], 'facility': 'Hepato-gastro-enterology department, Pitié Salpêtrière hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Lyès KHELOUFI', 'role': 'CONTACT', 'email': 'lyes.kheloufi@aphp.fr', 'phone': '01 84 82 74 83', 'phoneExt': '+33'}, {'name': 'Nicolas WEISS, MD,PhD', 'role': 'CONTACT', 'email': 'nicolas.weiss@aphp.fr', 'phone': '01 42 16 27 70', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Nicolas WEISS, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Dominique THABUT, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor', 'ipdSharing': 'YES', 'description': "Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.\n\nConsultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}