Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT06367127
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-16
First Post:
2024-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2024-01-15', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Beans Clamping in 1 minute', 'timeFrame': '1 minute', 'description': 'Moving beans from one container to another with tweezers in one minute, and then count the number of beans'}], 'secondaryOutcomes': [{'measure': "Participants' feedback on CBT1 test", 'timeFrame': '2 minutes', 'description': 'Participnants will be asked to complete the questionnaire of the feedback on CBT1 test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy', 'Covert Hepatic Encephalopathy']}, 'descriptionModule': {'briefSummary': 'Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.\n\nPresently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.\n\nMoving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Inverstigators will include about 200 healthy volunteers as the healthy control as well. And the data on participants' demographic characteristics, disease history, labratory characteristics and current treatment will be collected.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* written informed consent;\n* Age 18-70 years old;\n* Patients with clinical diagnosis of liver cirrhosis and without current OHE.\n\nExclusion Criteria:\n\n* Presence of other uncontrollable neuro-psychiatric or neurological diseases that affect cognitive function, such as Alzheimer's disease, Parkinson's disease, schizophrenia, etc.;\n* Clinically diagnosed as overt hepatic encephalopathy(OHE);\n* Consumption of hypnotic or sedative drug and psychotropic drug in the past 4 weeks;\n* Alcohol consumption \\>50 g/day within the past 3 months;\n* Conditions preventing the patient from completing the test independently (for instance, red-green color blindness, difficulty in comprehension)."}, 'identificationModule': {'nctId': 'NCT06367127', 'briefTitle': 'Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'Pingfanghu'}}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changzheng hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Lvping Sun', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Changzheng Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}