A Multicenter Prospective Randomized Controlled Trial of the Effectiveness of Amantadine Hydrochloride in Promoting Recovery of Function Following Severe Traumatic Brain Injury

Project Type
Collaborative
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Start Date:
10/1/2011
End Date:
9/30/2012
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Abstract:
After severe traumatic brain injury (TBI) some people remain unconscious or minimally conscious for weeks or months, and sometimes permanently. Severe disorders of consciousness prevent such individuals from regaining independence in self-care, communication, and mobility. Many different treatments have been recommended to promote recovery from severe brain injury, including various medications, sensory stimulation, electrical stimulation, and others. However, none of these treatments has been shown to be effective in well-controlled research. The purpose of this study was to test the effectiveness of the drug, amantadine hydrochloride in promoting recovery from severe TBI. 184 VS and MCS patients were randomized into amantadine treatment or placebo control treatment groups for this mutlicenter, double blind, randomized, placebo controlled study. Results showed that patients who received AH had faster functional recovery relative to those who received placebo, although the rate of improvement in the AH group slowed significantly compared to the placebo group after treatment was stopped. However, functional gains were maintained during the washout period. Conclusions drawn from the study were that AH is effective in accelerating the pace of recovery in VS and MCS patients with TBI within certain doses.