- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00700453
Video Game-Brain Functioning Reversibility Study
May 2, 2012 updated by: Indiana University
- 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.
Study Overview
Status
Unknown
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Radiology-- Research 2 building
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Indianapolis, Indiana, United States, 46202
- Riley Outpatient Center Rm 4300
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control 1 Group
Subjects randomized to the Control 1 group will abstain from playing any video games for the entire study participation.
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Subjects will abstain from all video game play during study participation.
Other Names:
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Active Comparator: VG1- Control 2 Group
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.
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Subjects will play 1 week of violent video game play followed by 1 week of no video game play.
Other Names:
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Active Comparator: VG1- VG2 group
Subjects randomized for VG1-VG2 group will play 60-120 minutes/day of a violent video game during weeks 2 & 3 of study participation.
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Subjects will play a violent video game for 2 weeks of study participation.
Other Names:
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Active Comparator: VG1-CT group
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.
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Subjects will play a violent video game for 1 week followed by 1 week of Cognitive Training program.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional Magnetic Resonance Imaging
Time Frame: Completed at visit 2, 3, and 4 (each visit 7-10 days apart)
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Completed at visit 2, 3, and 4 (each visit 7-10 days apart)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vincent P Mathews, MD, Indiana University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
June 11, 2008
First Submitted That Met QC Criteria
June 17, 2008
First Posted (Estimate)
June 18, 2008
Study Record Updates
Last Update Posted (Estimate)
May 3, 2012
Last Update Submitted That Met QC Criteria
May 2, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 0804-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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