Brain Functioning and Violent Video Game PlayNCT00700453
Video Game-Brain Functioning Reversibility Study
A study testing VG1 group (2 weeks of violent video game play) and Cognitive Training in people with Brain Functioning and Violent Video Game Play, run by Indiana University at 2 sites in United States.
Trial summary
1. Young adults who are exposed to 7-10 days of play of violent video games will show reduced activation in certain regions of the dorsolateral prefrontal cortex and anterior cingulate cortex. 2. Young adults who are exposed to 7-10 days of violent video games will show increased activation in regions of the amygdala. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Functioning and Violent Video Game Play
- What is being tested?
- VG1 group (2 weeks of violent video game play) and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Dec 2018
- 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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have K-BIT-2 Matrices IQ>70.
- Must be 18-29 years old for the entire study.
- Only males will participate in the study.
- Must be judged by the investigator to be reliable and cooperative for clinic visits and procedures.
- Must speak English, be proficient in spoken and written English, and have an educational level and understanding of English required to complete all tests and questionnaires. This is important because some of the tests require automatic and rapid processing of written English.
- Must have a baseline level of violent video game play averaging less than or equal to 2 hours per week in the year prior to the study, and must have a baseline level of total video game play averaging less than or equal to 5 hours per week in the year prior to the study. These values are based on research by Kronenberger et al. (2005a) showing that nonviolent control adolescent subjects averaged about 2-3 hours of video game play in a week (of which 1-2 hours are spent with violent video games), compared to aggressive adolescent subjects, who averaged about 4-7 hours of video game play per week (of which 3-4 hours are spent with violent video games). Green and Bavalier (2003) based their selection criteria for "action video game players" (VGP) on an average of 1 hour per day for 4 days a week of violent/action video game play and found differences between the VGP group and a non-VGP group on visual processing. It is important to select subjects who are not frequent game players in order for the experimental manipulation (8-16 hours of violent video game play) to be different from their baseline behavioral habits.
- Must be willing to make lifestyle changes about media habits during the 3-5 week duration of the study.
- Must have basic level of proficiency with computer to load and play video games.
Who cannot join
- Organic brain conditions or seizure disorder (history of febrile seizures with no neurological sequelae is acceptable).
- Any physical condition or risk that would preclude or invalidate an MRI.
- Any current mental health diagnosis (other than Adjustment Disorder), based on the Adult Inventory - 4 and follow-up questions from the interviewer, which would be defined as moderate or more severe using the Clinical Global Index - Severity.
- Treatment of a behavioral or emotional problem (excluding normal adjustment issues, such as adjustment to divorce) by a mental health professional in the past year.
- Any historical diagnoses of Attention-Deficit/Hyperactivity Disorder, Conduct Disorder, Oppositional-Defiant Disorder, Bipolar Disorder, Schizophrenia (or other disorder involving psychosis), Personality Disorders, or Pervasive Developmental Disorders.
- Any history of Attention-Deficit/Hyperactivity Disorder, Conduct Disorder, Oppositional-Defiant Disorder, Bipolar Disorder, Schizophrenia (or other disorder involving psychosis), Personality Disorders, or Pervasive Developmental Disorders in first degree relatives (mother, father, siblings, children).
- Current diagnosis of Substance Abuse or Dependence
- Use of psychotropic medication for treatment of a mental or behavioral disorder at any time in the study or in the year prior to the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Radiology-- Research 2 building
Indianapolis, Indiana, 46202
Riley Outpatient Center Rm 4300
Indianapolis, Indiana, 46202
About this study
- Young adults who are exposed to 7-10 days of play of violent video games will show reduced activation in certain regions of the dorsolateral prefrontal cortex and anterior cingulate cortex.
- Young adults who are exposed to 7-10 days of violent video games will show increased activation in regions of the amygdala.
- Young adults who abstain from violent video games for a week, after 7-10 days of play of violent video games, will show increased activation of regions in the dorsolateral prefrontal cortex and anterior cingulate cortex and decreased activation of the amygdala, on pre-post fMRI and compared to young adults who continue to play violent video games.
- Young adults who complete a computerized attention-training program after 7-10 days of violent video games will show increased activation of regions in the dorsolateral prefrontal cortex and anterior cingulate cortex and decreased activation of the amygdala, on pre-post fMRI and compared to young adults who continue to play violent video games.
Read the detailed description
After an initial screening visit (Visit 1) followed by a one-week period of monitoring their usual media habits, subjects will have a baseline functional magnetic resonance imaging (fMRI) scan (Visit 2). They will then be assigned in a 3:1 ratio to either one-week of violent video game play for 1-2 hours per day or no video game play for one week. Subjects will receive a second fMRI scan at the end of that week (Visit 3). Subjects who had played violent video games will then be assigned to one of three conditions (continued regular violent video game play, no video game play, or an intervention involving cognitive training of working memory) for one week, in order to investigate the persistence of any changes that are found after the first week of exposure. Subjects who had not played video games during the first week will continue to not play video games for the second week. Following that week, subjects will receive a third fMRI scan (Visit 4). One week after the third fMRI scan, subjects will have a final visit or phone call to check on the possibility of any issues with aggressive thoughts/feelings/behavior following the video game exposure in the study (Visit 5). Brain functioning will be measured using functional magnetic resonance imaging (fMRI) as the primary measurement methodology, with neuropsychological testing used as a secondary measurement methodology.
- Being tested
- Control group with no video game play, control 2, VG1 group (2 weeks of violent video game play), Cognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group with no video game playBehavioural
Also called Control 1 group
Subjects will abstain from all video game play during study participation.
control 2Behavioural
Also called Control 2 group
Subjects will play 1 week of violent video game play followed by 1 week of no video game play.
VG1 group (2 weeks of violent video game play)Behavioural
Also called VG1-VG2
Subjects will play a violent video game for 2 weeks of study participation.
Cognitive TrainingBehavioural
Also called VG1-CT group
Subjects will play a violent video game for 1 week followed by 1 week of Cognitive Training program.
| Study group | Role | What they receive |
|---|---|---|
| Control 1 Group | Active comparator | Subjects randomized to the Control 1 group will abstain from playing any video games for the entire study participation. Receives: Behavioral: Control group with no video game play |
| VG1- Control 2 Group | Active comparator | Subjects randomized to the Control 2 group will play a selected violent video game for 60-120 minutes/day during week 2 of the study and will abstain from any video game play during week 3 of the study. Receives: Behavioral: control 2 |
| VG1- VG2 group | Active comparator | Subjects randomized for VG1-VG2 group will play 60-120 minutes/day of a violent video game during weeks 2 \& 3 of study participation. Receives: Behavioral: VG1 group (2 weeks of violent video game play) |
| VG1-CT group | Active comparator | Subjects randomized to the VG1-CT group will play 60-120 minutes of a selected violent video game during week 2 of the study and play a selected computerized cognitive training program for 60-120 minutes/day during week 3 of the study. Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging
Measured: Completed at visit 2, 3, and 4 (each visit 7-10 days apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Functioning and Violent Video Game PlayStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- The Center for Successful Parenting Video Research Center
- Responsible party
- Sponsor
- Investigators
- Vincent P Mathews, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700453
- Sponsor's protocol ID
- 0804-07
- Status last verified
- Apr 2012
- First submitted
- 11 Jun 2008
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Game-Brain Functioning Reversibility Study
- ClinicalTrials.gov ID
- NCT00700453
- Acronym / sponsor ID
- 0804-07
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- The Center for Successful Parenting Video Research Center
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Jun 2008 (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.
- Young adults who are exposed to 7-10 days of play of violent video games will show reduced activation in certain regions of the dorsolateral prefrontal cortex and anterior cingulate cortex.
- Young adults who are exposed to 7-10 days of violent video games will show increased activation in regions of the amygdala.
- Young adults who abstain from violent video games for a week, after 7-10 days of play of violent video games, will show increased activation of regions in the dorsolateral prefrontal cortex and anterior cingulate cortex and decreased activation of the amygdala, on pre-post fMRI and compared to young adults who continue to play violent video games.
- Young adults who complete a computerized attention-training program after 7-10 days of violent video games will show increased activation of regions in the dorsolateral prefrontal cortex and anterior cingulate cortex and decreased activation of the amygdala, on pre-post fMRI and compared to young adults who continue to play violent video games.
Detailed description
After an initial screening visit (Visit 1) followed by a one-week period of monitoring their usual media habits, subjects will have a baseline functional magnetic resonance imaging (fMRI) scan (Visit 2). They will then be assigned in a 3:1 ratio to either one-week of violent video game play for 1-2 hours per day or no video game play for one week. Subjects will receive a second fMRI scan at the end of that week (Visit 3). Subjects who had played violent video games will then be assigned to one of three conditions (continued regular violent video game play, no video game play, or an intervention involving cognitive training of working memory) for one week, in order to investigate the persistence of any changes that are found after the first week of exposure. Subjects who had not played video games during the first week will continue to not play video games for the second week. Following that week, subjects will receive a third fMRI scan (Visit 4). One week after the third fMRI scan, subjects will have a final visit or phone call to check on the possibility of any issues with aggressive thoughts/feelings/behavior following the video game exposure in the study (Visit 5). Brain functioning will be measured using functional magnetic resonance imaging (fMRI) as the primary measurement methodology, with neuropsychological testing used as a secondary measurement methodology.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control 1 Group | Active comparator | Behavioral: Control group with no video game playSubjects randomized to the Control 1 group will abstain from playing any video games for the entire study participation. |
| VG1- Control 2 Group | Active comparator | Behavioral: control 2Subjects randomized to the Control 2 group will play a selected violent video game for 60-120 minutes/day during week 2 of the study and will abstain from any video game play during week 3 of the study. |
| VG1- VG2 group | Active comparator | Behavioral: VG1 group (2 weeks of violent video game play)Subjects randomized for VG1-VG2 group will play 60-120 minutes/day of a violent video game during weeks 2 \& 3 of study participation. |
| VG1-CT group | Active comparator | Behavioral: Cognitive TrainingSubjects randomized to the VG1-CT group will play 60-120 minutes of a selected violent video game during week 2 of the study and play a selected computerized cognitive training program for 60-120 minutes/day during week 3 of the study. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Have K-BIT-2 Matrices IQ>70.
- Must be 18-29 years old for the entire study.
- Only males will participate in the study.
- Must be judged by the investigator to be reliable and cooperative for clinic visits and procedures.
- Must speak English, be proficient in spoken and written English, and have an educational level and understanding of English required to complete all tests and questionnaires. This is important because some of the tests require automatic and rapid processing of written English.
Key exclusion criteria (8 listed)
- Organic brain conditions or seizure disorder (history of febrile seizures with no neurological sequelae is acceptable).
- Any physical condition or risk that would preclude or invalidate an MRI.
- Any current mental health diagnosis (other than Adjustment Disorder), based on the Adult Inventory - 4 and follow-up questions from the interviewer, which would be defined as moderate or more severe using the Clinical Global Index - Severity.
- Treatment of a behavioral or emotional problem (excluding normal adjustment issues, such as adjustment to divorce) by a mental health professional in the past year.
- Any historical diagnoses of Attention-Deficit/Hyperactivity Disorder, Conduct Disorder, Oppositional-Defiant Disorder, Bipolar Disorder, Schizophrenia (or other disorder involving psychosis), Personality Disorders, or Pervasive Developmental Disorders.
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 |
|---|---|---|
| Control group with no video game playAlso: Control 1 groupSubjects will abstain from all video game play during study participation. | Behavioural | Control 1 Group |
| control 2Also: Control 2 groupSubjects will play 1 week of violent video game play followed by 1 week of no video game play. | Behavioural | VG1- Control 2 Group |
| VG1 group (2 weeks of violent video game play)Also: VG1-VG2Subjects will play a violent video game for 2 weeks of study participation. | Behavioural | VG1- VG2 group |
| Cognitive TrainingAlso: VG1-CT groupSubjects will play a violent video game for 1 week followed by 1 week of Cognitive Training program. | Behavioural | VG1-CT group |
Primary outcome
Functional Magnetic Resonance Imaging
Time frame: Completed at visit 2, 3, and 4 (each visit 7-10 days apart)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Indiana University; Department of PsychiatryLink provided by the sponsor.
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.
Vincent P Mathews, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VG1 group (2 weeks of violent video game play) and Cognitive Training in people with Brain Functioning and Violent Video Game Play, run by Indiana University at 2 sites 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 8 inclusion and 8 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 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Functional Magnetic Resonance Imaging (time frame: Completed at visit 2, 3, and 4 (each visit 7-10 days apart)). 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 3 May 2012.