Sinemet and brain injury: functional versus statistical change and suggestions for future research designs

During the past decade the usage of dopaminergic agonists for the brain-injured population has become a more common treatment option during both the acute and subacute phases of recovery. We attempted to use Sinemet to address the functional limitations of a 74-year-old woman who was 7 months status post-traumatic brain injury secondary to a motor vehicle accident. The patient was administered a 3-month trial of Sinemet while continuing to receive structured sensory stimulation. Her baseline performance using Rappaport's Coma/Near-Coma (CNC) scale yielded a score in the moderate coma range. Weekly evaluations were conducted throughout the drug trial period using the CNC scale. Although the patient displayed modest improvement in her total score, functional change was negligible. Long-term follow-up suggested an absence of retention of earlier gains obtained on the CNC scale. The authors suggest that flawed research methodologies, heterogeneous patient populations, and potential difficulties obtaining reliable dependent measures makes the interpretation of brain injury research findings equivocal. However, given the many limitations, the current research design suggested that the long-term practical utility of Sinemet was unremarkable. Suggestions for future pharmacological research designs with the brain-injured population are discussed.