Effect of Music on Attention and Prospective Memory in Hepatic Encephalopathy

NCT01882855 | Withdrawn DMC

• 1 other identifier: S12-03729
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cirrhosis; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Lure Response Inhibition on Inhibitory Control Test

  The ICT will be administered with and without background music during a single visit.

Secondary Outcomes (1)

• Target Responses on Inhibitory Control Test

  The ICT will be administered with and without background music during a single visit.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least fifty subjects will be included in this study, including screening failures. There will be an equitable inclusion of both men and women in this study. Subjects must be between the ages of 18 and 70 to participate in this study. There is no restriction on race or ethnicity in this study. An effort will be made to recruit a diverse sample of participants.

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Medical Center

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Samuel Sigal, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: June 20, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (1)