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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06367127

Enrollment

200

Registered

2024-04-16

Start date

2023-10-09

Completion date

2024-12-31

Last updated

2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covert Hepatic Encephalopathy, Hepatic Encephalopathy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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).

Design outcomes

Primary

Measure	Time frame	Description
Number of Beans Clamping in 1 minute	1 minute	Moving beans from one container to another with tweezers in one minute, and then count the number of beans

Secondary

Measure	Time frame	Description
Participants' feedback on CBT1 test	2 minutes	Participnants will be asked to complete the questionnaire of the feedback on CBT1 test

Countries

China

Outcome results