Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening

NCT06367127 | Unknown DMC

• 1 other identifier: Pingfanghu
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. Presently, 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. Moving 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.

Conditions

Hepatic Encephalopathy; Covert Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Number of Beans Clamping in 1 minute

  Moving beans from one container to another with tweezers in one minute, and then count the number of beans

  1 minute

Secondary Outcomes (1)

• Participants' feedback on CBT1 test

  2 minutes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• written informed consent;
• Age 18-70 years old;
• Patients with clinical diagnosis of liver cirrhosis and without current OHE.

You may not qualify if:

• Presence of other uncontrollable neuro-psychiatric or neurological diseases that affect cognitive function, such as Alzheimer's disease, Parkinson's disease, schizophrenia, etc.;
• Clinically diagnosed as overt hepatic encephalopathy(OHE);
• Consumption of hypnotic or sedative drug and psychotropic drug in the past 4 weeks;
• Alcohol consumption \>50 g/day within the past 3 months;
• Conditions preventing the patient from completing the test independently (for instance, red-green color blindness, difficulty in comprehension).

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lvping Sun

  Shanghai Changzheng Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: April 16, 2024
• Study Start: October 9, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-01

Locations

CN (1)