Traumatic brain injury (TBI) is one of the most significant causes of disability to able bodied persons in the most productive period of their lives. The most common cause is high-speed transportation accidents, and these result in a mechanism of injury commonly described as diffuse axonal injury (DAI). DAI causes a reduction in the turnover of dopamine in the brain. Basic science research has suggested that increasing dopamine turnover at the synaptic level may have a beneficial effect on recovery from brain injury. One medication, Amantadine, has been the subject of considerable interest and clinical use. It stimulates the release of dopamine from the presynaptic neuron, inhibits the re-uptake of dopamine, may directly interact with post-synaptic dopamine receptors and is a weak N-methyl-D-aspartate (NMDA) antagonist. The concept study proposed herein will evaluate the early clinical use of Amantadine in TBI. This concept study is supported by the outcomes of a pilot study performed at UAB. However, the definite beneficial effect of Amantadine on brain injury recovery has never been demonstrated. Considering the widespread clinical application of Amantadine in TBI patients, a well-controlled prospective multicenter clinical trial should be carried out. This concept study, or any other(s) selected, will contribute to the multicenter TBI Clinical Trials Network. As Amantadine is generically available, there is little interest in it by the private sector. The study design is a single case double blind, randomized controlled trial. Utilizing well established outcome measures, including behavioral and cognitive, the investigators will attempt to establish the efficacy and side effects of Amantadine in the acute stages of recovery from TBI. This research has the significant possibility of reducing the disability and economic burden of these patients.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HD042687-05S1
Application #
7995917
Study Section
Special Emphasis Panel (ZHD1-RRG-K (07))
Program Officer
Ansel, Beth
Project Start
2002-09-05
Project End
2010-06-30
Budget Start
2009-12-03
Budget End
2010-06-30
Support Year
5
Fiscal Year
2010
Total Cost
$100,800
Indirect Cost
Name
University of Alabama Birmingham
Department
Physical Medicine & Rehab
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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