Diagnostik Af Minimal Hepatisk Encephalopati: Association Mellem Kontinuert Reaktionsstidsmåling Og EEG-indices
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Change in EEG spectral and frequency analysis with a clinically indicated standard treatment for minimal hepatic encephalopathy
研究概览
简要总结
Our purpose is to
- Examine the correlation between MDF in a resting EEG, recorded just before the CRT test, and the variance in reaction times indicated by the CRT index
- At simultaneous CRT and EEG recording, examine whether a change in EEG is seen immediately before an extended reaction time occurs (defined by the 75th percentile). This will shed light on a direct pathophysiological association between what is measured with EEG and CRT.
- Investigate whether cyclicity can be detected in the continuous reaction times and if so, whether amplitude and wavelength in this cyclic activity are correlated to EEG parameters.
- Examine whether a response to standard HE treatment can be detected with EEG in patients who are thought to suffer from it. As well as if baseline outcome predict future hepatic encephalopathy.
- With a view to further validating our findings, investigators want to correlate results from EEG and CRT with the most internationally widespread psychometric test, the Portosystemic Encephalopathy test (PSE), which necessitates the establishment of Danish normal values. A secondary purpose of this study is therefore
- To establish Danish normal values for the PSE test and the Animal Naming test in Danes
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Organic brain disease (eg previous epilepsy, apoplexy, dementia)
- •Hyponatraemia (Na <124 mmol / L)
- •Sepsis one week prior to tests.
- •Heart failure (EC less than 30% or NYHA class III and IV)
- •Severe chronic obstructive pulmonary disease (GOLD stage 3 and 4 ie FEV1 / FVC below 0.7 and FEV1 <50% of expected value)
- •Highly controllable diabetes (HbA1C> 60 mmol / mol)
- •Renal failure (eGFR below 60)
- •Known neurological diseases (epilepsy, stroke, dementia)
- •Intake of coffee or alcohol 6 hours before tests and change of dose in psychoactive drugs within 6 days of the test (morphine, antipsychotics, antidepressants) -
结局指标
主要结局
Change in EEG spectral and frequency analysis with a clinically indicated standard treatment for minimal hepatic encephalopathy
时间窗: Up to 60 months
Some patients will be found eligible for treatment with lactulose or rifaximin due to signs of minimal hepatic encephalopathy. Investigators will use EEG relative theta and delta activity to measure the efficacy of the treatment.
Concordant changes in reaction times and in EEG spectral and frequency analysis
时间窗: Up to 60 months
During CRT 150 reaction times are measured. Investigators want to measure if prolonged reaction times \>75 percentile are preceded by spectral and frequency changes in EEG. For EEG investigators will assess relative theta and delta activity. EEG and CRT will be done simultaneously.
Observation of cyclic activity in continous reaction times (CRT measures)
时间窗: Up to 60 months
Apply mathematically modeled time analysis to establish cyclicity in the 150 measures reaction times and examine if cyclic activity correlates to relative theta and delta activity in the EEG.
次要结局
未报告次要终点
研究者
Mette Munk Lauridsen
Associate professor
University of Southern Denmark