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OpenTrials
Completed

NCT Number: NCT02154282

iPod Games in Hepatic Encephalopathy

To see if using ipod games can improve mental functioning

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ipod games

Behavioral

Patients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures

Primary outcomes

  1. 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

Secondary outcomes

  1. Improvement in health-related quality of life

    Time frame: 8 weeks

    Sickness Impact Profile will be used before and after the treatment

  2. 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

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2014
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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