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| Sponsor: | Kessler Medical Rehabiliation Research Center |
|---|---|
| Collaborators: |
University of Medicine and Dentistry New Jersey Cephalon |
| Information provided by: | Kessler Foundation |
| ClinicalTrials.gov Identifier: | NCT00489892 |
Purpose
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.
Hypotheses
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury Severe Traumatic Brain Injury |
Drug: Modafinil |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of Pharmacological Treatment of Working Memory Impairment After Traumatic Brain Injury: Evaluation With fMRI |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | December 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
We will include only those subjects who have sustained moderate to severe initial injuries, as defined by an initial 24-hour Glasgow Coma Scale 128 scores below 13. In the event that a GCS score is not available, subjects will only be included if there is sufficient medical documentation that would allow for a post-hoc estimation of initial GCS, or if other confirmatory data (e.g., positive anatomic neuroimaging findings, focal neurologic signs) are available. Individuals with a history of prior moderate to severe head injury, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will not be included as subjects. In addition, a score of 11 or greater on the Mini Mental Status Exam will be required to insure that subject can participate effectively in the study protocol. Because of potential effects on cognition and hemodynamic response, subjects currently taking benzodiazepines, narcotics, neuroleptics, anticonvulsants, antispasticity agents or psychostimulants will not be included.
In addition, any patient that is on medications that may interact with any of the study medications (e.g. birth control bills or cyclosporin). Psychiatric symptoms and substance abuse history will be obtained using a structured psychiatric interview, the Diagnostic Interview Schedule 129DIS. In addition patients with history of drug dependency, hypertension out of control, significant cardiac disease, or inability to undergo MRI. (e.g. metalworker, Medtronic infusion pump)
Contacts and Locations| Contact: Elie P Elovic, M.D. | (973) 243-6815 | eelovic@kmrrec.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 |
More Information
| Study ID Numbers: | D-437-02, 0120020166, M-166-2002 |
| Study First Received: | June 20, 2007 |
| Last Updated: | July 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00489892 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
traumatic brain injury TBI working memory |
modafinil fMRI MRI |
|
Craniocerebral Trauma Nervous System Diseases Physiological Effects of Drugs Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Central Nervous System Stimulants Trauma, Nervous System |
Brain Diseases Protective Agents Neuroprotective Agents Modafinil Pharmacologic Actions Therapeutic Uses Brain Injuries Central Nervous System Agents |
