Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits
The purpose of this research study is to evaluate whether Vyvanse, a psychostimulant, can help with attention deficits due to traumatic brain injury (TBI). Vyvanse is currently approved for the treatment of Attention-Deficit/Hyperactivity (ADHD). The exact effects this drug may have on attention deficits caused by TBI are not known, but we expect that Vyvanse will be of some help in treating those types of problems as well. The study will utilize functional magnetic resonance imaging (fMRI) methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response.
Traumatic Brain Injury
Attention Deficit Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Psychostimulant Treatment of TBI-Related Attention Deficits: fMRI Analysis of Neural Mechanisms of Response|
- Assessment of various components of attention, related cognitive processes, ADHD symptoms, emotional status, and quality of life ratings using various tests and scales such as Word List learning, ADHD Rating Scale, Beck Depression Inventory, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Evaluation of which types of patients are most likely to benefit from treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- The study will utilize fMRI methods, as well as neurobehavioral measures, to elucidate neural mechanisms of response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Vayvanse capsule, 30-70 mg, each morning for 6 weeks.
30 mg - 70 mg capsules taken every morning for 6 weeks
Other Name: VyvanseProcedure: fMRI
Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
Symptoms of inattentiveness, impulsivity, and poor persistence have been observed in both children and adults following traumatic brain injury (TBI). These often are among the most prominent symptoms manifested and may contribute to interference in a variety of other functional domains. Although there has been some use of psychostimulant medication to treat TBI-acquired attention deficits, it remains a relatively uncommon clinical practice. This study, by highlighting mechanisms of action, could serve to promote the appropriate use of this type of treatment for the patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000064
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Michael G Tramontana, Ph.D.||Vanderbilt University|