Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures.

An international panel reviewed the methodology for clinical trials of spinal cord injury (SCI), and provided recommendations for the valid conduct of future trials. This is the second of four papers. It examines clinical trial end points that have been used previously, reviews alternative outcome tools and identifies unmet needs for demonstrating the efficacy of an experimental intervention after SCI. The panel focused on outcome measures that are relevant to clinical trials of experimental cell-based and pharmaceutical drug treatments. Outcome measures are of three main classes: (1) those that provide an anatomical or neurological assessment for the connectivity of the spinal cord, (2) those that categorize a subject's functional ability to engage in activities of daily living, and (3) those that measure an individual's quality of life (QoL). The American Spinal Injury Association impairment scale forms the standard basis for measuring neurologic outcomes. Various electrophysiological measures and imaging tools are in development, which may provide more precise information on functional changes following treatment and/or the therapeutic action of experimental agents. When compared to appropriate controls, an improved functional outcome, in response to an experimental treatment, is the necessary goal of a clinical trial program. Several new functional outcome tools are being developed for measuring an individual's ability to engage in activities of daily living. Such clinical end points will need to be incorporated into Phase 2 and Phase 3 trials. QoL measures often do not correlate tightly with the above outcome tools, but may need to form part of Phase 3 trial measures.

Neurorehabilitation following right thalamic infarct: effects of cognitive retraining on functional performance.

We treated the cognitive impairments of a 69-year-old male, that persisted 7 months after an infarction in the distribution of the right posterior cerebral artery. The infarct produced a 20% reduction in right cerebral blood flow, established by positron emission tomography (PET). Neuropsychological status was characterized by marked hemivisuospatial inattention, visuoperceptual and perceptuomotor dysfunction, and impaired visual memory. A multiple-baselines across behaviors design was utilized to assess effects of specific interventions on targeted cognitive functions. We found significant improvement in attention to left hemispace in response to directed interventions. Considerable gains were also realized in perceptuomotor abilities, mobility, and activities of daily living. Results indicated process-specific effects of strategic cognitive interventions, initiated 7 months postonset.

Computerized tomographic findings in neuro-Behcet's disease.

Exacerbations of neurologic deficit in a patient with neuro-Behcet's disease were accompanied by a contrast-enhancing lesion on cerebral computerized tomography. Such lesions are consistent with the histopathologic findings in neuro-Behcet's disease, and can increase the clinical suggestion of the diagnosis in patients whose first symptoms are restricted to the nervous system.