Aggressive BehaviorNCT00267891
Brain Changes in Adolescents While Imagining and Observing Aggressive Behavior
An observational study of Aggressive Behavior, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use functional magnetic resonance imaging (fMRI) to examine what happens in the brains of adolescents when they are exposed to violent media and how imagining aggressive behavior affects brain function. Read more about this study
- Who is it for?
- Ages 14 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aggressive Behavior
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2005to 12 Aug 2010
- Phase
- Observational
- 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 14 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- In all the studies, participants will consist of male adolescent healthy, native English-speaking, right-handed volunteers. Participants will range in age from 14 to 17 years old and they will be included regardless of race.
Who cannot join
- Non-native English speakers and non-right handers will be excluded, as will non-neurologically normal volunteers. Subjects younger than 14 and older than 17 years of age will be excluded.
- Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing will be excluded from the study due to the possible dangerous effects of the magnet upon metal objects in the body.
- Individuals with a neurological or psychiatric history, including significant aggressive behavior and drug abuse, or with a medical condition that would compromise our interpretation of the fMRI results will be excluded. Adolescents with attentional, cognitive, or learning difficulties or impairments cannot take part in the study. An intelligence quotient less then 80 will be exclusion criteria for this study. Individuals with a current or past history of post-traumatic stress disorder or other psychiatric disorders or individuals with a history of physical or sexual abuse will be excluded as they may be disturbed by the exposure to violent stimuli. Furthermore, we will exclude adolescents who take centrally acting medications. The presence or absence of these conditions will be determined by a standardized neuropsychiatric interview, questionnaires, ability testing, and standard phone or in-person intake (see screening section).
- Adolescents who have been trained in martial arts will be excluded from our studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Changes in Activation Patterns in the Ventro-Medial Prefrontal Cortex of Healthy Adolescents During the Imagination and Observation of Aggressive Behavior
This study will use functional magnetic resonance imaging (fMRI) to examine what happens in the brains of adolescents when they are exposed to violent media and how imagining aggressive behavior affects brain function. The study will measure physiological changes (such as the amount of electricity generated by the skin, heart rate, and breathing rate) related to these tasks during fMRI. MRI uses a magnetic field and radio waves to obtain images of body organs and tissues. For fMRI, the subject performs certain tasks during the MRI scanning to examine changes in the brain regions that are involved with those tasks. During the scan, the subject lies in a metal cylinder (the scanner), wearing earplugs to muffle loud noises that occur with the scanning.
Healthy right-handed native English-speaking males between 14 and 17 years of age may be eligible for this study. Candidates are screened with a neurological examination and neuropsychological testing that includes questions about their feelings, experiences, and behavior, and tests of reading level and intelligence.
Read more
Participants undergo fMRI and fill out questionnaires before and after the scanning. Some children are asked to play 20 minutes of video games before the test. During the scan, the child views short neutral video clips and video clips of people fighting or imagine self-defense situations. The child is asked to rate the video clips for their aggressive content or tell how he or she feels about the imagined situations. Two small straps are wrapped around the child's index and middle fingers to measure changes in the amount of electricity generated by the skin, and a strap at the ring finger measures the child's heart rate. A band around the child's chest records breathing rates.
Children who cannot or do not want to undergo MRI testing may be asked to view commercially available video clips of people fighting and neutral video scenes, such as sports scenes. They are asked to rate them on their violent content and excitement, or to rate the video games they have played on their violent/nonviolent content and their popularity. In addition, the children fill out questionnaires about their media use and exposure to violence.
All participating families are contacted by telephone 1 day and 2 weeks after the experiment for parents to answer questions about how the child has been doing and for the children to answer questions about their feelings.
Read the detailed description
Objective. The purpose of the protocol is to localize the prefrontal cortical regions mediating aggressive behavior. Utilizing two different experimental neuropsychological tasks during functional MRI, we will investigate hypotheses regarding the role of the ventro-medial prefrontal cortex in processing imagined and observed aggressive behavior. Additionally, we will determine the relationship between non-frontal neural structures involved in emotional expression, such as the amygdala, and the prefrontal structures involved in executive functions that may modulate aggressive behavior. We will record skin conductance responses (SCRs), heart rates, and respiration during the experiments to investigate autonomic changes during the processing of aggressive behavior.
Study Population. In three separate studies, normal adolescent volunteers will participate in experiments dealing with processing of aggressive behavior using functional magnetic resonance imaging (fMRI). In addition, we will conduct two pre-studies in normal adolescent volunteers in order to determine appropriate stimuli for the fMRI studies.
Design. The experiments we are conducting will employ within-subject, rapid event-related fMRI designs to determine whether the observation and imagination of aggressive behavior deactivates the ventro-medial prefrontal cortex (VM-PFC) and how varying intensities of imagined and observed aggressive acts may influence changes in activation patterns in the VM-PFC.
Outcome Measures. The data collected will consist of fMRI activation images corresponding to varying intensities of observed or imagined aggression, questionnaire results, amplitudes of the skin conductance responses, heart rates, and respiration parameters. The results gained from this protocol will provide further evidence for the role of the ventro-medial prefrontal cortex in processing aggressive behavior, particularly in adolescents.
- Conditions
- Aggressive Behavior
- Keywords
- Healthy Control Subjects, Aggression, Prefrontal Cortex Function, Children and Adolescents, Healthy Volunteer, HV
- Medical subject headings
- Aggression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study start14 Dec 2005
- Study completion12 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aggressive BehaviorStudies 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
- Observational
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267891
- Sponsor's protocol ID
- 060048
- Other IDs
- 06-N-0048
- Status last verified
- 12 Aug 2010
- First submitted
- 21 Dec 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Anderson CA, Bushman BJ. Effects of violent video games on aggressive behavior, aggressive cognition, aggressive affect, physiological arousal, and prosocial behavior: a meta-analytic review of the scientific literature. Psychol Sci. 2001 Sep;12(5):353-9. doi: 10.1111/1467-9280.00366.
PubMed 11554666Anderson CA, Dill KE. Video games and aggressive thoughts, feelings, and behavior in the laboratory and in life. J Pers Soc Psychol. 2000 Apr;78(4):772-90. doi: 10.1037//0022-3514.78.4.772.
PubMed 10794380Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
PubMed 1948051
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Activation Patterns in the Ventro-Medial Prefrontal Cortex of Healthy Adolescents During the Imagination and Observation of Aggressive Behavior
- ClinicalTrials.gov ID
- NCT00267891
- Acronym / sponsor ID
- 060048
- Conditions
- Aggressive Behavior
- Keywords
- Healthy Control Subjects, Aggression, Prefrontal Cortex Function, Children and Adolescents, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Dec 2005
- Study completion
- 12 Aug 2010
- First posted
- 21 Dec 2005 (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 study will use functional magnetic resonance imaging (fMRI) to examine what happens in the brains of adolescents when they are exposed to violent media and how imagining aggressive behavior affects brain function. The study will measure physiological changes (such as the amount of electricity generated by the skin, heart rate, and breathing rate) related to these tasks during fMRI. MRI uses a magnetic field and radio waves to obtain images of body organs and tissues. For fMRI, the subject performs certain tasks during the MRI scanning to examine changes in the brain regions that are involved with those tasks. During the scan, the subject lies in a metal cylinder (the scanner), wearing earplugs to muffle loud noises that occur with the scanning.
Healthy right-handed native English-speaking males between 14 and 17 years of age may be eligible for this study. Candidates are screened with a neurological examination and neuropsychological testing that includes questions about their feelings, experiences, and behavior, and tests of reading level and intelligence.
Participants undergo fMRI and fill out questionnaires before and after the scanning. Some children are asked to play 20 minutes of video games before the test. During the scan, the child views short neutral video clips and video clips of people fighting or imagine self-defense situations. The child is asked to rate the video clips for their aggressive content or tell how he or she feels about the imagined situations. Two small straps are wrapped around the child's index and middle fingers to measure changes in the amount of electricity generated by the skin, and a strap at the ring finger measures the child's heart rate. A band around the child's chest records breathing rates.
Children who cannot or do not want to undergo MRI testing may be asked to view commercially available video clips of people fighting and neutral video scenes, such as sports scenes. They are asked to rate them on their violent content and excitement, or to rate the video games they have played on their violent/nonviolent content and their popularity. In addition, the children fill out questionnaires about their media use and exposure to violence.
All participating families are contacted by telephone 1 day and 2 weeks after the experiment for parents to answer questions about how the child has been doing and for the children to answer questions about their feelings.
Detailed description
Objective. The purpose of the protocol is to localize the prefrontal cortical regions mediating aggressive behavior. Utilizing two different experimental neuropsychological tasks during functional MRI, we will investigate hypotheses regarding the role of the ventro-medial prefrontal cortex in processing imagined and observed aggressive behavior. Additionally, we will determine the relationship between non-frontal neural structures involved in emotional expression, such as the amygdala, and the prefrontal structures involved in executive functions that may modulate aggressive behavior. We will record skin conductance responses (SCRs), heart rates, and respiration during the experiments to investigate autonomic changes during the processing of aggressive behavior.
Study Population. In three separate studies, normal adolescent volunteers will participate in experiments dealing with processing of aggressive behavior using functional magnetic resonance imaging (fMRI). In addition, we will conduct two pre-studies in normal adolescent volunteers in order to determine appropriate stimuli for the fMRI studies.
Design. The experiments we are conducting will employ within-subject, rapid event-related fMRI designs to determine whether the observation and imagination of aggressive behavior deactivates the ventro-medial prefrontal cortex (VM-PFC) and how varying intensities of imagined and observed aggressive acts may influence changes in activation patterns in the VM-PFC.
Outcome Measures. The data collected will consist of fMRI activation images corresponding to varying intensities of observed or imagined aggression, questionnaire results, amplitudes of the skin conductance responses, heart rates, and respiration parameters. The results gained from this protocol will provide further evidence for the role of the ventro-medial prefrontal cortex in processing aggressive behavior, particularly in adolescents.
Study design
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- In all the studies, participants will consist of male adolescent healthy, native English-speaking, right-handed volunteers. Participants will range in age from 14 to 17 years old and they will be included regardless of race.
Key exclusion criteria (4 listed)
- Non-native English speakers and non-right handers will be excluded, as will non-neurologically normal volunteers. Subjects younger than 14 and older than 17 years of age will be excluded.
- Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing will be excluded from the study due to the possible dangerous effects of the magnet upon metal objects in the body.
- Individuals with a neurological or psychiatric history, including significant aggressive behavior and drug abuse, or with a medical condition that would compromise our interpretation of the fMRI results will be excluded. Adolescents with attentional, cognitive, or learning difficulties or impairments cannot take part in the study. An intelligence quotient less then 80 will be exclusion criteria for this study. Individuals with a current or past history of post-traumatic stress disorder or other psychiatric disorders or individuals with a history of physical or sexual abuse will be excluded as they may be disturbed by the exposure to violent stimuli. Furthermore, we will exclude adolescents who take centrally acting medications. The presence or absence of these conditions will be determined by a standardized neuropsychiatric interview, questionnaires, ability testing, and standard phone or in-person intake (see screening section).
- Adolescents who have been trained in martial arts will be excluded from our studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 11554666Anderson CA, Bushman BJ. Effects of violent video games on aggressive behavior, aggressive cognition, aggressive affect, physiological arousal, and prosocial behavior: a meta-analytic review of the scientific literature. Psychol Sci. 2001 Sep;12(5):353-9. doi: 10.1111/1467-9280.00366.
- Background: PubMed 10794380Anderson CA, Dill KE. Video games and aggressive thoughts, feelings, and behavior in the laboratory and in life. J Pers Soc Psychol. 2000 Apr;78(4):772-90. doi: 10.1037//0022-3514.78.4.772.
- Background: PubMed 1948051Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
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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?
An observational study of Aggressive Behavior, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 1 inclusion and 4 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267891, which also lists 3 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 2 Jul 2017.