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临床试验/NCT06367127
NCT06367127Enrolling By Invitation不适用

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

Shanghai Changzheng Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Number of Beans Clamping in 1 minute

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Number of Beans Clamping in 1 minute

时间窗: 1 minute

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

次要结局

  • Participants' feedback on CBT1 test(2 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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