iPod Games in Hepatic Encephalopathy

Cirrhosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154282
• Other study ID #: BAJAJ0013
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: September 6, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To see if using ipod games can improve mental functioning

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Fibrosis
• Hepatic Encephalopathy

Intervention

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

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks	No
Secondary	Improvement in health-related quality of life	Sickness Impact Profile will be used before and after the treatment	8 weeks	No
Secondary	Improvement in brain MRI parameters	change in detailed imaging parameters related to diffusion tensor imaging, resting state and voxel-based morphometry	4 weeks	No