Effect of Music on Attention and Prospective Memory in Hepatic Encephalopathy
Withdrawn before enrolling
Conditions studied: Cirrhosis, Hepatic Encephalopathy
In brief
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).
Key facts
- Study ID
- NCT01882855
- Run by
- NYU Langone Health
- People needed
- 0
- Starts
- 2012-12-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-03-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ambulatory patient with cirrhosis
- Able to provide informed consent
You may not qualify if…
- History of alcohol abuse within six months
- Active gastrointestinal bleeding
- Unable to provide informed consent
Where it is running
- NYU Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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