Effect of Music on Attention and Prospective Memory in Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Lure Response Inhibition on Inhibitory Control Test
研究概览
简要总结
Hepatic encephalopathy (HE) is a potentially reversible, metabolically caused complication of acute or chronic liver diseases such as cirrhosis. Due to the diseased liver's inability to remove toxins such as ammonia, which is produced in the gastrointestinal tract, the ammonia accumulates in the brain and causes forgetfulness, confusion, disorientation, concentration and memory problems, changes in mood, decreased alertness and responsiveness, changes in sleep habits, muscle tremors and stiffness, speech impairments, uncontrollable movements, agitation.
This study will examine music as a possible external factor that could contribute to impairment in attention and progressive memory in cirrhotic patients while driving. Sustaining attention is important for learning and remembering new information, for e.g. keeping the car within lane and paying attention to cyclists and pedestrians. Prospective memory is the ability to remember to perform previously intended tasks at the appropriate time or occasion, for instance remembering the correct exit while driving on the highway. Impairment in any of these areas may result in serious consequences for patient with cirrhosis. There is evidence that some subsets of cirrhotic patients have a diminished ability to drive and significantly more motor vehicle crashes and traffic violations. In these patients, listening to music while driving may further jeopardize their driving ability, which in turn may lead to reduced quality of life and increased medical costs (from motor vehicle accidents).
This is a cross-sectional study designed to determine if there is any effect of listening to music on attention and prospective memory in patients with cirrhosis. For these purposes, subjects will be asked to come for one study visit, which will last approximately 2 hours. During this visit, subjects will undergo a series of screening procedures (consent, assignment of subject identification number, demographics, medical history, physical examination, vitals, height, weight, and eligibility assessment). If they are found eligible, subjects will undergo several neuropsychological assessments to measure any effect of music on attention and prospective memory. These assessments include including Number Connection Test (NCT), Digit Symbol Test (DST), Cambridge Prospective Memory Test (CAMPROMPT) and Inhibitory Control Test (ICT).
详细描述
Cirrhosis occurs when scar tissue replaces healthy liver tissue, partially blocking blood flow and preventing the liver's ability to control infections, removes bacteria and toxins from the blood, and to produce proteins to regulate blood clotting and bile to absorb fats and fat-soluble vitamins. With an estimated prevalence between five and ten percent, cirrhosis is the twelfth leading cause of death by disease, leading to 27,000 deaths per year. Heavy alcohol consumption and hepatotropic viruses (hepatitis B and C) are the major contributors to this disease's prevalence (NDDIC, 2003).
Hepatic encephalopathy (HE) is a potentially reversible, metabolically caused complication of acute or chronic liver diseases such as cirrhosis, which is characterized by neuropsychiatric abnormalities. Nearly 70% of cirrhotic patients experience mild levels of HE and approximately 30% of end-stage patients experience significant HE symptoms, many approaching coma (Mullen et al., 1999). Although the pathophysiology of HE is not yet clearly understood, the accumulation of ammonia in the brain due to the liver's inability to remove toxins (including ammonia) is thought to play a key role in the pathogenesis of HE. Other factors, which are not mutually exclusive, include increased GABA-ergic tone, selective alterations of the blood-brain barrier permeability and changes in neurotransmitter systems. The broad spectrum of symptoms in HE include forgetfulness, confusion, disorientation, concentration and memory problems, changes in mood, decreased alertness and responsiveness, changes in sleep habits, muscle tremors and stiffness, speech impairments, uncontrollable movements, agitation (Ferenci et al., 2002).
The diagnosis of HE is essentially based on clinical history and laboratory findings such as elevated ammonia levels. Additionally, specialized psychometric tests such as the number connection test (NCT), Digit Symbol Test (DST) and Psychometric Hepatic Encephalopathy Score (PHES) have been used in quantifying the minor deficits that may be present in patients with early HE.
Minimal hepatic encephalopathy (MHE) is a category of early HE without any overt neuropsychiatric symptoms but with subtle cognitive deficits (Ferenci et al., 1998). It is a common complication of cirrhosis and has been reported in 20% to 74% of patients (Dhiman et al., 2010), depending on the test used for diagnosis. It results in deficits in specific cognitive domains such as attention, vigilance, response inhibition, executive function and prospective memory. These deficits are often not apparent from a routine neurological exam or MMSE but can be detected on psychometric testing. The prompt identification and treatment of MHE are essential because MHE predicts progression to overt HE and impairs the capacity to drive which can have a significant impact on patients' quality of life (Romero-Gomez et al., 2001; Wein et al, 2004) .
Treatment of HE with or without liver transplantation has been shown to reverse the cognitive deficits and improve quality of life (Prasad et al., 2007; Sidhu et al., 2011). Although the PHES and NCT are the gold standard for diagnosing MHE, their utility is limited due to expensive copyright, a need for trained psychologists and the lack of reimbursements from insurance companies. A simpler test would therefore be beneficial to internists who could easily implement it in the clinic setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Ambulatory patient with cirrhosis
- •Able to provide informed consent
排除标准
- •History of alcohol abuse within six months
- •Active gastrointestinal bleeding
- •Unable to provide informed consent
结局指标
主要结局
Lure Response Inhibition on Inhibitory Control Test
时间窗: The ICT will be administered with and without background music during a single visit.
次要结局
- Target Responses on Inhibitory Control Test(The ICT will be administered with and without background music during a single visit.)
