NCT01000064

Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits

Psychostimulant Treatment of TBI-Related Attention Deficits: fMRI Analysis of Neural Mechanisms of Response

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Traumatic Brain Injury
• Attention Deficit Disorder

Interventions

Type	Name	Description
DRUG	Vyvanse	30 mg - 70 mg capsules taken every morning for 6 weeks.
PROCEDURE	fMRI	Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit.
DRUG	Placebo	Placebo capsules taken every morning for 6 weeks.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-12-01
• Completion: 2015-05-01
• First posted: 2009-10-22
• Last updated: 2017-05-19
• Results posted: 2017-05-19

Locations

1 site across 1 country: United States