Hepatic EncephalopathyNCT02154282
iPod Games in Hepatic Encephalopathy
A study testing ipod games in people with Hepatic Encephalopathy and Cirrhosis, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
To see if using ipod games can improve mental functioning Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis
- What is being tested?
- ipod games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
To see if using ipod games can improve mental functioning
- Conditions
- Hepatic Encephalopathy, Cirrhosis
- Being tested
- ipod games
- Keywords
- hepatic encephalopathy, covert hepatic encephalopathy, cirrhosis
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipod gamesBehavioural
Patients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures
| Study group | Role | What they receive |
|---|---|---|
| ipod games | Experimental | Administered ipod games with cognitive testing before and after Receives: Behavioral: ipod games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (2)
Improvement in health-related quality of life
Sickness Impact Profile will be used before and after the treatment
Measured: 8 weeks
Improvement in brain MRI parameters
change in detailed imaging parameters related to diffusion tensor imaging, resting state and voxel-based morphometry
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154282
- Sponsor's protocol ID
- BAJAJ0013
- Status last verified
- Sep 2016
- First submitted
- 27 May 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPod Games in Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT02154282
- Acronym / sponsor ID
- BAJAJ0013
- Conditions
- Hepatic Encephalopathy, Cirrhosis
- Keywords
- hepatic encephalopathy, covert hepatic encephalopathy, cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To see if using ipod games can improve mental functioning
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ipod games | Experimental | Behavioral: ipod gamesAdministered ipod games with cognitive testing before and after |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ipod gamesPatients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures | Behavioural | ipod games |
Primary outcome
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
2 secondary outcomes
Improvement in health-related quality of life
Time frame: 8 weeks
Improvement in brain MRI parameters
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ipod games in people with Hepatic Encephalopathy and Cirrhosis, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in cognitive test performance with iPod games (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.