Electrophysiological monitoring in clinical trials. Roche Neuropathy Study Group.
Electrophysiological testing remains an important efficacy parameter in clinical neuropathy trials. The quality of nerve conduction studies in reported trials varies greatly, and may be responsible for negative results. We report the utilization of an expert core lab for electrophysiological testing. With the core lab, the variability of repeat testing is comparable to that of a single, excellent laboratory. Motor conduction velocities demonstrated a coefficient of variation of 3% and sensory conduction velocities 4% across 60 study sites. The distal motor evoked potential amplitudes varied by 13% at the ankle, and 10% at the wrist. The sensory potential amplitudes varied by 16% at the ankle, and 11% at the wrist in 60 sites. The overall monitoring rate in all submitted nerve conduction tracings was 36.6%. Our results show that an expert core lab can improve the electrophysiological quality of clinical trial data with the potential to show small changes in nerve conduction velocities and in both motor and sensory potential amplitudes.
Bril
V
V
University of Toronto, The Toronto Hospital, General Division, Ontario, Canada.
Ellison
R
R
Ngo
M
M
Bergstrom
B
B
Raynard
D
D
Gin
H
H
D003929:Diabetic Neuropathies / Q000175:diagnosis*; D004576:Electromyography / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D008475:Median Nerve / Q000166:cytology / Q000502:physiology; D009046:Motor Neurons / Q000502:physiology; D009431:Neural Conduction; D009475:Neurons, Afferent / Q000502:physiology; D009482:Neurophysiology / Q000592:standards; D010543:Peroneal Nerve / Q000166:cytology / Q000502:physiology; D015203:Reproducibility of Results; D013497:Sural Nerve / Q000166:cytology / Q000502:physiology