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From the Neuroimaging Research Unit (Drs. Sormani, Rovaris, Valsasina, and Filippi) and Clinical Trials Unit (Dr. Comi), Department of Neurology, Scientific Institute and University Ospedale San Raffaele, Milan, and Unit of Clinical Epidemiology and Trials (Dr. Sormani), National Institute for Cancer Research, Genoa, Italy; and University of Texas Health Science Center at Houston (Dr. Wolinsky).
Address correspondence and reprint requests to Dr. M. Filippi, Neuroimaging Research Unit, Department of Neurology, Scientific Institute and University Ospedale San Raffaele, via Olgettina 60, 20132 Milan, Italy; e-mail: filippi.massimo{at}hsr.it
The measurement errors associated with two techniques for brain atrophy assessment in multiple sclerosis (MS) were estimated. The measurement error of a semiautomated, nonnormalized technique with partial brain coverage was about twofold higher than that of a fully automated, normalized technique with full brain coverage (Structural Image Evaluation of Normalized Atrophy software [SIENA]). As shown by the analysis of data from a clinical trial of glatiramer acetate, the use of SIENA increases the study power to detect a treatment effect on brain volume changes in MS patients.
Received September 26, 2003. Accepted in final form December 10, 2003.
Drs. Sormani, Rovaris, Wolinsky, Comi, and Filippi have received honoraria from Teva Pharmaceutical Industries. (All of the above except for Dr. Rovaris received in excess of $10,000.)
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