NCT02154282

Brief Summary

To see if using ipod games can improve mental functioning

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

3.5 years

First QC Date

May 27, 2014

Last Update Submit

September 6, 2016

Conditions

Hepatic EncephalopathyCirrhosis

Keywords

hepatic encephalopathycovert hepatic encephalopathycirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Improvement in health-related quality of life

    8 weeks

  • Improvement in brain MRI parameters

    4 weeks

Study Arms (1)

ipod games

EXPERIMENTAL

Administered ipod games with cognitive testing before and after

Behavioral: ipod games

Interventions

ipod gamesBEHAVIORAL

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

ipod games

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Hepatic EncephalopathyFibrosis

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 3, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

US(1)