iPod Games in Hepatic Encephalopathy

September 6, 2016 updated by: Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
To see if using ipod games can improve mental functioning

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cirrhosis proven by biopsy, radiology or endoscopy
  • Age 18-70
  • Able to give informed consent
  • Cognitive dysfunction defined by impaired performance on standard cognitive tests

Exclusion Criteria:

  • Illicit drug or alcohol use within 3 months
  • Trans-jugular intra-hepatic porto-systemic shunt (TIPS) placement
  • Need for psychoactive medications apart from continuous anti-depressants or methadone
  • Any focal neurological deficit or neuro-muscular disease
  • Inability to function with an iPod
  • Inability to understand English

For MRI: inability to perform brain MRI is an exclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ipod games
Administered ipod games with cognitive testing before and after
Behavioral: ipod games
Patients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in cognitive test performance with iPod games
Time Frame: 8 weeks
improvement in cognitive performance on a battery of cognitive tests (Psychometric Hepatic Encephalopathy Score, Inhibitory Control test and Verbal Learning) after iPod tests
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in health-related quality of life
Time Frame: 8 weeks
Sickness Impact Profile will be used before and after the treatment
8 weeks
Improvement in brain MRI parameters
Time Frame: 4 weeks
change in detailed imaging parameters related to diffusion tensor imaging, resting state and voxel-based morphometry
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAJAJ0013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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