Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333931
Status:
UNKNOWN
Last Update Posted:
2006-06-06
First Post:
2006-06-02
Brief Title:
Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Sponsor:
Michael E DeBakey VA Medical Center
Organization:
Michael E DeBakey VA Medical Center
Study Overview
Official Title:
Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to identify changes in brain functioning which are related to reduced frequency andor intensity of impulsive aggressive actions after treatment of PTSD-related impulsive aggression with either phenytoin or cognitive behavioral therapy
Detailed Description:
Objective One One study objective is to evaluate potential effect sizes of phenytoin and cognitive behavioral therapy for PTSD-related impulsive aggression
Hypothesis Phenytoin and cognitive behavioral therapy are hypothesized to be effective in the treatment of PTSD-related impulsive aggression based on studies previously outlined
Plan Patients enrolled in this pilot study will be randomized to receive an eight-week course of treatment with phenytoin or cognitive behavioral therapy in the Trauma Recovery Program at the Veteranss Affairs Medical Center in Houston Texas
Objective Two Another study objective is to begin to attempt to delineate potential neural correlates of treatment-related reductions in PTSD-related impulsive aggression
Hypothesis Potential neural correlates of treatment-related reduction in intensity andor severity of impulsive-aggressive acts are hypothesized to include changes in 1 thalamic activation reflecting more effective thalamic sensory gating with anticipation of increased activation of the thalamus post-treatment 2 activation of brain regions associated with verbal information processing with the anticipation of increased activation of these regions post-treatment 3 activation of prefrontal regions including the anticipation of increased activation of the medial andor orbital prefrontal cortex post-treatment 4 amygdalar activation with the anticipation of decreased activation of the amygdala post-treatment 5 hippocampal activation with the anticipation of increased activation of the hippocampus post-treatment andor 6 right-left hemispheric dissociation of brain processing of stimuli with the anticipation of greater degrees of bilaterality of brain processing of stimuli post-treatment Specifically greater degrees of activation of left hemispheric brain structures are anticipated in post-treatment fMRI scans
Plan Patients with PTSD-associated impulsive aggression will undergo an eight-week course of treatment with phenytoin or CBT Treatment-related changes in impulsive-aggressive acts will be correlated with changes in brain activation comparing pre- and post-treatment fMRI scans utilizing a standardized Go-No Go task which has been used in the study of impulsive aggressive individuals
Hypothesis Phenytoin and cognitive behavioral therapy are hypothesized to be effective in the treatment of PTSD-related impulsive aggression based on studies previously outlined
Plan Patients enrolled in this pilot study will be randomized to receive an eight-week course of treatment with phenytoin or cognitive behavioral therapy in the Trauma Recovery Program at the Veteranss Affairs Medical Center in Houston Texas
Objective Two Another study objective is to begin to attempt to delineate potential neural correlates of treatment-related reductions in PTSD-related impulsive aggression
Hypothesis Potential neural correlates of treatment-related reduction in intensity andor severity of impulsive-aggressive acts are hypothesized to include changes in 1 thalamic activation reflecting more effective thalamic sensory gating with anticipation of increased activation of the thalamus post-treatment 2 activation of brain regions associated with verbal information processing with the anticipation of increased activation of these regions post-treatment 3 activation of prefrontal regions including the anticipation of increased activation of the medial andor orbital prefrontal cortex post-treatment 4 amygdalar activation with the anticipation of decreased activation of the amygdala post-treatment 5 hippocampal activation with the anticipation of increased activation of the hippocampus post-treatment andor 6 right-left hemispheric dissociation of brain processing of stimuli with the anticipation of greater degrees of bilaterality of brain processing of stimuli post-treatment Specifically greater degrees of activation of left hemispheric brain structures are anticipated in post-treatment fMRI scans
Plan Patients with PTSD-associated impulsive aggression will undergo an eight-week course of treatment with phenytoin or CBT Treatment-related changes in impulsive-aggressive acts will be correlated with changes in brain activation comparing pre- and post-treatment fMRI scans utilizing a standardized Go-No Go task which has been used in the study of impulsive aggressive individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None