Acquired Brain InjuryNCT01518010
Multi-player Online Video Games for Cognitive Rehabilitation
A study testing Play game in people with Acquired Brain Injury, run by University of Portsmouth.
Trial summary
This research project aims to find out if a multiplayer online video game can provide therapeutic benefit for people who have survived a brain injury. Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Play game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have survived an acquired brain injury
- Have progressed through the acute stage of treatment and rehabilitation
- Be attending a day centre periodically
- Have an interest in playing video games
- Be physically capable of playing a video game, with adjustments to the user interface as required
- Be capable of giving or withholding consent
- Have access to suitable computer with internet access at day centre
Who cannot join
- Any history of photosensitive epilepsy
- Any history of ill effects due to playing video games, or if any ill-effects are shown when playing video games
- On advice of medical staff or carer
Trial locations and contacts
No sites are listed yet.
Jason E Colman contact
About this study
This research project aims to find out if a multiplayer online video game can provide therapeutic benefit for people who have survived a brain injury.
Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Players of online multiplayer games behave altruistically and form friendships (Wang and Wang, 2008). These positive emotional effects may enhance cognitive rehabilitation, because the cognitive and emotional sides of rehabilitation are connected (Mateer, 2005).
Read more
The hypothesis is thus: that playing multiplayer online games can be a useful form of cognitive rehabilitation for brain-injured people.
This research will identify whether or not multi-player online video games may be used as a complementary therapeutic tool. A further aim is to develop guidelines which would help others considering the use of video games for cognitive rehabilitation.
Read the detailed description
Purpose and design
This research aims to find out if massively multi-player online games (MMOs), a relatively new type of video game, can be used as a form of therapy for people who have survived an acquired brain injury.
Numerous previous studies have shown that video games can be used as therapy in many contexts. However, there is some evidence that video games are not an effective form of cognitive rehabilitation for brain injury survivors (Malec et al., 1984). The difference in this research is that MMOs incorporate social interaction into the game play experience. It is proposed that this strengthening of social bonds will be more beneficial than a similar single-player game.
Due to the narrow focus of the research it is anticipated that the number of potential participants will be small, on the order of ten participants. It is recognised that such a small sample size is not compatible with a randomised controlled trial. Instead, the research will employ a single-subject research design, where a higher number of participants will strengthen the external validity of the results.
The research question and design have been developed primarily by the Chief Investigator (PhD student), with critique from the supervisory team. Feedback has also been received from healthcare professionals who have been contacted by the C.I.
Participants will be asked for their feedback on a video game and its user interface. This is to ensure that the video game is suitable for the participant, and that the participant is able to play it. This stage is expected to consist of three or four sessions of 30 mins duration, every 2 weeks.
Participants will then be asked to play the video game for a number of sessions. The number of sessions is 21. The duration of each session is one hour. The sessions are to be held once per week.
Null/alternative hypotheses
The null hypotheses are that a single-player video game will not improve cognitive skills; and that a multi-player online video game will not improve cognitive skills. The alternative hypotheses are that a single-player game will improve cognitive skills, and a multi-player online game will provide further improvement.
Study design
The first stage of the research will be to design and refine a prototype online multi-player video game, working in collaboration with participants, firstly able-bodied, and then disabled. The researcher will work with each participant to develop a user interface which enables him or her to play the video game.
The study will then employ a single-case research design for each disabled participant. An RCT would not be valid given the expected number of participants. Time-series data will be collected in three phases: to obtain a baseline; to measure the effects of a single-player video game; and to measure the effects of a multi-player online game. Each phase has seven sessions. The sessions are one hour, weekly.
During the baseline phase, The participant will engage in a non-game task using the interface defined in the pre-trial phase. This phase may compensate for researcher effects. For the next phase, the participant will engage in a single-player version of the video game. For the final phase, the participant will engage in a multi-player online game.
Player activity in the single- and multi-player games will be logged for analysis. Interviews with participants will be used to build a thick narrative of each participants' experience over the course of the study.
Recruitment
Participants will be recruited by contacting head injury units, day care centres, and organisations such as Headway and the ARNI Trust. The C.I. will meet with potential participants who express an interest in the study.
A cornerstone of rehabilitation is that the goals are relevant to the client's everyday life. Therefore the details of how any individual's cognitive improvements will be measured must be based on a dialogue with each individual.
Consent
Informed consent must be given by a participant before any involvement in the study.
A participant information sheet will be provided. The C.I. will be present to talk through the issues with the participant. The NHS guidelines for writing clear information sheets will be followed.
Due to the nature of the participants' injuries, particular care and emphasis is placed on establishing capacity to give consent. The Department of Health gives guidelines on gauging capacity but family members and care workers will be a key source of guidance.
It is expected that participants will provide a written signature on a consent form, but again due to the nature of the participant's injuries this may not be possible. In this case the verbal consent of the participant would be recorded and witness(es) would sign the form.
Risks, burdens and benefits
The main medical risk of playing video games is the possibility of epileptic seizure due to photosensitive epilepsy, (PSE). Minor risks are: the possibility of aches and pains; eye strain; and stress caused by extended periods of vigilance. These risks are mitigated by conducting the research at day care centres where medical staff will be on hand, and by limiting play to one hour per week, broken into smaller play sessions (e.g. 3 * 20 mins). Additionally, again to minimise risk of photosensitive seizure, screen luminance will be kept to a minimum.
Other issues to consider when using video games as therapy are: video game "addiction"; violent content; and the offensive nature of some games. The issue of any potential addiction is mitigated by the short playing times; the issue of game suitability will be managed by previewing and discussing game content with participant, family members and carers as appropriate.
Potential benefits to participants: Playing a suitable game should provide feelings of well-being and improved self esteem. With the added social aspect of multi-player online games, participants could also feel less isolated. These improvements in emotional health may have beneficial effects on cognitive skills such as communication.
Confidentiality
Participant personal details will be kept confidential. When data is reported, random numeric IDs will be used to refer to individuals. Guidelines issued by the Office of National Statistics will be followed when tabulated data contains cells with zeros or extremely low numbers, so that potential identification of participants is prevented.
- Conditions
- Acquired Brain Injury
- Being tested
- Play game
- Keywords
- Brain injury, Cognitive rehabilitation, Video game
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play gameBehavioural
Participants engage in non-game activity (establish baseline) 7 * 1 hr weekly; play single-player game 7 * 1 hr weekly; play multi-player game 7 * 1 hr weekly.
| Study group | Role | What they receive |
|---|---|---|
| GamePlay | Experimental | Not described Receives: Behavioral: Play game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Player in-game activity data
All player activity is logged on server with timestamp. Data to be logged:
- Player movement (ID, location, timestamp)
- Messages sent (Sender and recipient IDs, text, timestamp)
- In-game objects created or modified (participant ID, object ID, object type, timestamp)
Each weekly session will produce one block of this data. The 21 blocks constitute time series data which will be analysed for evidence of improvement in cognitive skills.
Measured: Time series data collected each hourly session, weekly, for 21 weeks
Secondary outcomes (1)
Player attitudes
Each session in debriefing, players will be asked about their attitudes and feelings about the effects of playing video games
Measured: Weekly , for 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Colman, University of Portsmouth
- Investigators
- Jason E Colman, Principal investigator, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518010
- Sponsor's protocol ID
- COLMAN
- Status last verified
- Jan 2012
- First submitted
- 15 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mateer, C. (2005) Fundamentals of cognitive rehabilitation. In Halligan, P., and Wade, D. (Eds.) Effectiveness of rehabilitation for cognitive defects. Oxford University Press
Griffiths M. Video games and health. BMJ. 2005 Jul 16;331(7509):122-3. doi: 10.1136/bmj.331.7509.122. No abstract available.
PubMed 16020833Wang CC, Wang CH. Helping others in online games: prosocial behavior in cyberspace. Cyberpsychol Behav. 2008 Jun;11(3):344-6. doi: 10.1089/cpb.2007.0045.
PubMed 18537505Malec, J., Jones, R., Rao, N., Stubbs, K. (1984) Video game practice effects on sustained attention in patients with craniocerebral trauma. Cognitive Rehabilitation 2 (4): 18 - 23
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-player Online Video Games for Cognitive Rehabilitation
- ClinicalTrials.gov ID
- NCT01518010
- Acronym / sponsor ID
- COLMAN
- Conditions
- Acquired Brain Injury
- Keywords
- Brain injury, Cognitive rehabilitation, Video game
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 25 Jan 2012 (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.
This research project aims to find out if a multiplayer online video game can provide therapeutic benefit for people who have survived a brain injury.
Video games provide therapeutic benefits in many contexts (Griffiths, 2005). Players of online multiplayer games behave altruistically and form friendships (Wang and Wang, 2008). These positive emotional effects may enhance cognitive rehabilitation, because the cognitive and emotional sides of rehabilitation are connected (Mateer, 2005).
The hypothesis is thus: that playing multiplayer online games can be a useful form of cognitive rehabilitation for brain-injured people.
This research will identify whether or not multi-player online video games may be used as a complementary therapeutic tool. A further aim is to develop guidelines which would help others considering the use of video games for cognitive rehabilitation.
Detailed description
Purpose and design
This research aims to find out if massively multi-player online games (MMOs), a relatively new type of video game, can be used as a form of therapy for people who have survived an acquired brain injury.
Numerous previous studies have shown that video games can be used as therapy in many contexts. However, there is some evidence that video games are not an effective form of cognitive rehabilitation for brain injury survivors (Malec et al., 1984). The difference in this research is that MMOs incorporate social interaction into the game play experience. It is proposed that this strengthening of social bonds will be more beneficial than a similar single-player game.
Due to the narrow focus of the research it is anticipated that the number of potential participants will be small, on the order of ten participants. It is recognised that such a small sample size is not compatible with a randomised controlled trial. Instead, the research will employ a single-subject research design, where a higher number of participants will strengthen the external validity of the results.
The research question and design have been developed primarily by the Chief Investigator (PhD student), with critique from the supervisory team. Feedback has also been received from healthcare professionals who have been contacted by the C.I.
Participants will be asked for their feedback on a video game and its user interface. This is to ensure that the video game is suitable for the participant, and that the participant is able to play it. This stage is expected to consist of three or four sessions of 30 mins duration, every 2 weeks.
Participants will then be asked to play the video game for a number of sessions. The number of sessions is 21. The duration of each session is one hour. The sessions are to be held once per week.
Null/alternative hypotheses
The null hypotheses are that a single-player video game will not improve cognitive skills; and that a multi-player online video game will not improve cognitive skills. The alternative hypotheses are that a single-player game will improve cognitive skills, and a multi-player online game will provide further improvement.
Study design
The first stage of the research will be to design and refine a prototype online multi-player video game, working in collaboration with participants, firstly able-bodied, and then disabled. The researcher will work with each participant to develop a user interface which enables him or her to play the video game.
The study will then employ a single-case research design for each disabled participant. An RCT would not be valid given the expected number of participants. Time-series data will be collected in three phases: to obtain a baseline; to measure the effects of a single-player video game; and to measure the effects of a multi-player online game. Each phase has seven sessions. The sessions are one hour, weekly.
During the baseline phase, The participant will engage in a non-game task using the interface defined in the pre-trial phase. This phase may compensate for researcher effects. For the next phase, the participant will engage in a single-player version of the video game. For the final phase, the participant will engage in a multi-player online game.
Player activity in the single- and multi-player games will be logged for analysis. Interviews with participants will be used to build a thick narrative of each participants' experience over the course of the study.
Recruitment
Participants will be recruited by contacting head injury units, day care centres, and organisations such as Headway and the ARNI Trust. The C.I. will meet with potential participants who express an interest in the study.
A cornerstone of rehabilitation is that the goals are relevant to the client's everyday life. Therefore the details of how any individual's cognitive improvements will be measured must be based on a dialogue with each individual.
Consent
Informed consent must be given by a participant before any involvement in the study.
A participant information sheet will be provided. The C.I. will be present to talk through the issues with the participant. The NHS guidelines for writing clear information sheets will be followed.
Due to the nature of the participants' injuries, particular care and emphasis is placed on establishing capacity to give consent. The Department of Health gives guidelines on gauging capacity but family members and care workers will be a key source of guidance.
It is expected that participants will provide a written signature on a consent form, but again due to the nature of the participant's injuries this may not be possible. In this case the verbal consent of the participant would be recorded and witness(es) would sign the form.
Risks, burdens and benefits
The main medical risk of playing video games is the possibility of epileptic seizure due to photosensitive epilepsy, (PSE). Minor risks are: the possibility of aches and pains; eye strain; and stress caused by extended periods of vigilance. These risks are mitigated by conducting the research at day care centres where medical staff will be on hand, and by limiting play to one hour per week, broken into smaller play sessions (e.g. 3 * 20 mins). Additionally, again to minimise risk of photosensitive seizure, screen luminance will be kept to a minimum.
Other issues to consider when using video games as therapy are: video game "addiction"; violent content; and the offensive nature of some games. The issue of any potential addiction is mitigated by the short playing times; the issue of game suitability will be managed by previewing and discussing game content with participant, family members and carers as appropriate.
Potential benefits to participants: Playing a suitable game should provide feelings of well-being and improved self esteem. With the added social aspect of multi-player online games, participants could also feel less isolated. These improvements in emotional health may have beneficial effects on cognitive skills such as communication.
Confidentiality
Participant personal details will be kept confidential. When data is reported, random numeric IDs will be used to refer to individuals. Guidelines issued by the Office of National Statistics will be followed when tabulated data contains cells with zeros or extremely low numbers, so that potential identification of participants is prevented.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GamePlay | Experimental | Behavioral: Play game |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have survived an acquired brain injury
- Have progressed through the acute stage of treatment and rehabilitation
- Be attending a day centre periodically
- Have an interest in playing video games
- Be physically capable of playing a video game, with adjustments to the user interface as required
Key exclusion criteria (3 listed)
- Any history of photosensitive epilepsy
- Any history of ill effects due to playing video games, or if any ill-effects are shown when playing video games
- On advice of medical staff or carer
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 |
|---|---|---|
| Play gameParticipants engage in non-game activity (establish baseline) 7 * 1 hr weekly; play single-player game 7 * 1 hr weekly; play multi-player game 7 * 1 hr weekly. | Behavioural | GamePlay |
Primary outcome
Player in-game activity data
Time frame: Time series data collected each hourly session, weekly, for 21 weeks
All player activity is logged on server with timestamp. Data to be logged: * Player movement (ID, location, timestamp) * Messages sent (Sender and recipient IDs, text, timestamp) * In-game objects created or modified (participant ID, object ID, object type, timestamp) Each weekly session will produce one block of this data. The 21 blocks constitute time series data which will be analysed for evidence of improvement in cognitive skills.
1 secondary outcome
Player attitudes
Time frame: Weekly , for 21 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- BackgroundMateer, C. (2005) Fundamentals of cognitive rehabilitation. In Halligan, P., and Wade, D. (Eds.) Effectiveness of rehabilitation for cognitive defects. Oxford University Press
- Background: PubMed 16020833Griffiths M. Video games and health. BMJ. 2005 Jul 16;331(7509):122-3. doi: 10.1136/bmj.331.7509.122. No abstract available.
- Background: PubMed 18537505Wang CC, Wang CH. Helping others in online games: prosocial behavior in cyberspace. Cyberpsychol Behav. 2008 Jun;11(3):344-6. doi: 10.1089/cpb.2007.0045.
- BackgroundMalec, J., Jones, R., Rao, N., Stubbs, K. (1984) Video game practice effects on sustained attention in patients with craniocerebral trauma. Cognitive Rehabilitation 2 (4): 18 - 23
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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.
Jason E Colman contact
Jason E Colman principal investigator
University of Portsmouth
Questions about this trial
What is this clinical trial studying?
A study testing Play game in people with Acquired Brain Injury, run by University of Portsmouth.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason E Colman (jason.e.colman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Player in-game activity data (time frame: Time series data collected each hourly session, weekly, for 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518010, which also lists 4 linked publications.
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 25 Jan 2012.