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iPod Games in Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy, Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ipod games
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring hepatic encephalopathy, covert hepatic encephalopathy, cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ipod games

Arm Description

Administered ipod games with cognitive testing before and after

Outcomes

Primary Outcome Measures

Improvement in cognitive test performance with iPod games
improvement in cognitive performance on a battery of cognitive tests (Psychometric Hepatic Encephalopathy Score, Inhibitory Control test and Verbal Learning) after iPod tests

Secondary Outcome Measures

Improvement in health-related quality of life
Sickness Impact Profile will be used before and after the treatment
Improvement in brain MRI parameters
change in detailed imaging parameters related to diffusion tensor imaging, resting state and voxel-based morphometry

Full Information

First Posted
May 27, 2014
Last Updated
September 6, 2016
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02154282
Brief Title
iPod Games in Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To see if using ipod games can improve mental functioning

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Cirrhosis
Keywords
hepatic encephalopathy, covert hepatic encephalopathy, cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ipod games
Arm Type
Experimental
Arm Description
Administered ipod games with cognitive testing before and after
Intervention Type
Behavioral
Intervention Name(s)
ipod games
Intervention Description
Patients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures
Primary Outcome Measure Information:
Title
Improvement in cognitive test performance with iPod games
Description
improvement in cognitive performance on a battery of cognitive tests (Psychometric Hepatic Encephalopathy Score, Inhibitory Control test and Verbal Learning) after iPod tests
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Improvement in health-related quality of life
Description
Sickness Impact Profile will be used before and after the treatment
Time Frame
8 weeks
Title
Improvement in brain MRI parameters
Description
change in detailed imaging parameters related to diffusion tensor imaging, resting state and voxel-based morphometry
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

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iPod Games in Hepatic Encephalopathy

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