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Effect of Music on Attention and Prospective Memory in Hepatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT01882855
Recruitment Status : Withdrawn (Dr. Sigal no longer with NYUMC)
First Posted : June 20, 2013
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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).


Condition or disease
Cirrhosis Hepatic Encephalopathy

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Effect of Music on Attention and Prospective Memory in Hepatic Encephalopathy
Study Start Date : December 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016





Primary Outcome Measures :
  1. Lure Response Inhibition on Inhibitory Control Test [ Time Frame: The ICT will be administered with and without background music during a single visit. ]

Secondary Outcome Measures :
  1. Target Responses on Inhibitory Control Test [ Time Frame: The ICT will be administered with and without background music during a single visit. ]

Biospecimen Retention:   Samples With DNA
Blood samples


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Ambulatory patient with cirrhosis
  • Able to provide informed consent

Exclusion Criteria:

  • History of alcohol abuse within six months
  • Active gastrointestinal bleeding
  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882855


Locations
United States, New York
NYU Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Samuel Sigal, MD NYU Langone Medical Center

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01882855     History of Changes
Other Study ID Numbers: S12-03729
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases