Value of repeated measures of nerve conduction and quantitative sensory testing in a diabetic neuropathy trial.
Conduct of a large, multicenter trial of the aldose reductase inhibitor zenarestat provided data on the reproducibility of multiple electrophysiologic (nerve conduction studies, NCS) and quantitative sensory (QST) tests. Baseline and 12-month electrophysiologic data from approximately 1100 patients at multiple centers were available for analysis. Intersite variability contributed minimally to overall test variance. All NCS tests were highly reproducible. Cool thermal and vibration QST thresholds, as measured by CASE IV instrumentation, were also highly reproducible. Intersubject variance accounted for the majority of variance for all parameters measured. Repeating NCS and QST measures decreased sample sizes needed to show statistical significance. Consideration of these observations, particularly with regard to QST, should aid in the design of future clinical trials investigating neuropathy.
Bird
Shawn J
SJ
Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Brown
Mark J
MJ
Spino
Cathie
C
Watling
Sharon
S
Foyt
Howard L
HL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000449:Aldehyde Reductase / Q000037:antagonists & inhibitors; D000465:Algorithms; D003080:Cold Temperature; D003627:Data Interpretation, Statistical; D003929:Diabetic Neuropathies / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology*; D004594:Electrophysiology; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D009431:Neural Conduction / Q000502:physiology*; D009475:Neurons, Afferent / Q000502:physiology*; D011799:Quinazolines / Q000627:therapeutic use*; D015203:Reproducibility of Results; D018401:Sample Size; D013697:Thermosensing / Q000502:physiology; D014732:Vibration
D000449:Aldehyde Reductase; D004791:Enzyme Inhibitors; D006442:Glycated Hemoglobin; D011799:Quinazolines; C064920:FR 74366