Efficacy of Pharmacological Treatment of Working Memory Impairment After Traumatic Brain Injury: Evaluation With fMRI
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|ClinicalTrials.gov Identifier: NCT00489892|
Recruitment Status : Unknown
Verified July 2007 by Kessler Foundation.
Recruitment status was: Recruiting
First Posted : June 21, 2007
Last Update Posted : July 25, 2007
This study is designed to examine the effects of a wake-promoting agent (Modafinil) on working memory (WM) in persons with moderate to severe TBI utilizing a double blinded placebo controlled methodology. Our approach is to evaluate participants with BOLD fMRI and a limited neuropsychological battery to examine WM performance before and after pharmacological intervention.
- Because increased cognitive effort (as a function of decreased efficiency after TBI) is presumed to underlie fMRI activation dispersion that is seen during central executive WM tasks, we anticipate an attenuation of cerebral activation in prefrontal cortex during pharmacological intervention with Modafinil when compared to placebo administration on the mPASAT and vigilance testing.
- There will be a correlation between the decreased dispersion of the fMRI signal on scans and improvement in neuropsychological measures when individuals are on Modafinil that is not seen when they are taking placebo.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Severe Traumatic Brain Injury||Drug: Modafinil||Not Applicable|
Work from our institution has shown that moderate and severe TBI subjects demonstrate an altered cerebral representation when they attempt to process a verbal WM task. Specifically, our data show a post-TBI pattern of activation that is dispersed and more lateralized to the right hemisphere, as compared to healthy controls. Taken together, we interpret these findings to mean that it is requires more cerebral resources for TBI subjects to process tasks that were previously more automatic. In other words, their processing is less efficient. This is consistent with TBI patients’ self-reports of needing to expend greater cognitive effort to perform such tasks, both in the lab and in everyday life. Our preliminary data was the first step in understanding the cerebral substrate of these difficulties. However, simply indicating that individuals with TBI have a WM problem is not enough. The development of targeted interventions to ameliorate these deficits is the next step in the treatment process.
The present proposal has important implications for TBI rehabilitation. One of the major goals of cognitive remediation is to help TBI patients learn new information more accurately and efficiently, and to improve their performance in activities of everyday life. 123 Because WM impairments are so prevalent in TBI, the present study can help to shed light on potential treatment alternatives for these potentially devastating problems. In spite of the prevalence and popularity of cognitive remediation strategies and procedures, there remains little empirical support for their efficacy, and virtually no understanding of the underlying neurocognitive processes that facilitate intervention. The ability to develop a potentially efficacious treatment modality, which has a solid foundation, would be immensely beneficial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Pharmacological Treatment of Working Memory Impairment After Traumatic Brain Injury: Evaluation With fMRI|
|Study Start Date :||August 2003|
|Estimated Study Completion Date :||December 2008|
- mPASAT [ Time Frame: Pre-Treatment, Post-Treatment ]
- Dispersion of fMRI signal [ Time Frame: Pre-Treatment, Post-Treatment ]
- Simple Vigilance Task [ Time Frame: Pre-Treatment, Post-Treatment ]
- Neuropsychological Battery (Digit Vigilance Task, California Verbal Learning Test, Digit Span and Continuous Performance Task) [ Time Frame: Pre-Treatment, Post-Treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489892
|Contact: Elie P Elovic, M.D.||(973) firstname.lastname@example.org|
|United States, New Jersey|
|Kessler Medical Rehabilitation Research & Education Corporation||Recruiting|
|West Orange, New Jersey, United States, 07052|
|Principal Investigator: Elie P Elovic, M.D.|
|Sub-Investigator: Glenn Wylie, Ph.D|
|Sub-Investigator: John DeLuca, Ph.D.|
|Principal Investigator:||Elie P Elovic, M.D.||Kessler Medical Rehabilitation Research & Education Corporation|