Electrophysiological monitoring in clinical trials

V. Bril, R. Ellison, M. Ngo, B. Bergstrom, D. Raynard, H. Gin, A. Belanger, L. Cote, T. Benstead, L. P. Heffernan, R. Bergenstal, F. Taylor, R. Bernstein, R. Miller, F. W. Bertelsmann, R. L M Strijers, A. Boulton, W. Schady, A. Carrington, D. BrunetW. Carter, J. Nickols, S. Rudnicki, A. Charles, A. Starr, Y. Zhu, D. Clarke, D. Smith, V. Cwik, S. DeCherney, R. Fisher, S. Dippe, R. Goodell, J. Dupre, I. Hramiak, C. J V Fox, A. Bissessar, R. Freeman, C. Godin, A. Lamontagne, R. Goldberg, K. Sharma, M. Kato, D. A. Greene, E. Feldman, G. Grunberger, J. F. Selwa, Y. Harati, C. Gooch, R. Kolimas, K. Hermansen, J. Christensen, V. Nielson, J. Hilsted, M. Damholt, L. B. Blatt, I. Ipp, T. Anderson, P. Jennings, C. K. Laljee, J. Jervell, E. Jorum, T. Ganes, F. Kennedy, W. Litchy, C. Kilo, R. Frere, B. Green, G. King, J. Rosenszweig, A. Herzog, V. Koivisto, A. M. Seppalainen, D. Lau, P. Bourque, D. Preston, S. Levin, S. A. Chrissian, A. MacCuish, P. Jamal, J. I. Malone, J. Korthals, L. Olansky, W. D. Shipley, M. Pfeifer, J. Farquhar, N. Pillay, D. Porte, G. Poticha, S. Gulevich, P. Raskin, R. Greenlee, G. Rayman, S. J. Wroe, J. Rosenstock, F. Gul, C. Saudek, David Cornblath, J. Scarpello

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1368-1373
Number of pages6
JournalMuscle and Nerve
Volume21
Issue number11
DOIs
StatePublished - 1998
Externally publishedYes

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Neural Conduction
Clinical Trials
Wrist
Ankle
Motor Evoked Potentials

Keywords

  • Clinical trials
  • Diabetic neuropathy
  • Electrophysiology
  • Monitoring laboratory
  • Nerve conduction studies

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Bril, V., Ellison, R., Ngo, M., Bergstrom, B., Raynard, D., Gin, H., ... Scarpello, J. (1998). Electrophysiological monitoring in clinical trials. Muscle and Nerve, 21(11), 1368-1373. https://doi.org/10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7

Electrophysiological monitoring in clinical trials. / Bril, V.; Ellison, R.; Ngo, M.; Bergstrom, B.; Raynard, D.; Gin, H.; Belanger, A.; Cote, L.; Benstead, T.; Heffernan, L. P.; Bergenstal, R.; Taylor, F.; Bernstein, R.; Miller, R.; Bertelsmann, F. W.; Strijers, R. L M; Boulton, A.; Schady, W.; Carrington, A.; Brunet, D.; Carter, W.; Nickols, J.; Rudnicki, S.; Charles, A.; Starr, A.; Zhu, Y.; Clarke, D.; Smith, D.; Cwik, V.; DeCherney, S.; Fisher, R.; Dippe, S.; Goodell, R.; Dupre, J.; Hramiak, I.; Fox, C. J V; Bissessar, A.; Freeman, R.; Godin, C.; Lamontagne, A.; Goldberg, R.; Sharma, K.; Kato, M.; Greene, D. A.; Feldman, E.; Grunberger, G.; Selwa, J. F.; Harati, Y.; Gooch, C.; Kolimas, R.; Hermansen, K.; Christensen, J.; Nielson, V.; Hilsted, J.; Damholt, M.; Blatt, L. B.; Ipp, I.; Anderson, T.; Jennings, P.; Laljee, C. K.; Jervell, J.; Jorum, E.; Ganes, T.; Kennedy, F.; Litchy, W.; Kilo, C.; Frere, R.; Green, B.; King, G.; Rosenszweig, J.; Herzog, A.; Koivisto, V.; Seppalainen, A. M.; Lau, D.; Bourque, P.; Preston, D.; Levin, S.; Chrissian, S. A.; MacCuish, A.; Jamal, P.; Malone, J. I.; Korthals, J.; Olansky, L.; Shipley, W. D.; Pfeifer, M.; Farquhar, J.; Pillay, N.; Porte, D.; Poticha, G.; Gulevich, S.; Raskin, P.; Greenlee, R.; Rayman, G.; Wroe, S. J.; Rosenstock, J.; Gul, F.; Saudek, C.; Cornblath, David; Scarpello, J.

In: Muscle and Nerve, Vol. 21, No. 11, 1998, p. 1368-1373.

Research output: Contribution to journalArticle

Bril, V, Ellison, R, Ngo, M, Bergstrom, B, Raynard, D, Gin, H, Belanger, A, Cote, L, Benstead, T, Heffernan, LP, Bergenstal, R, Taylor, F, Bernstein, R, Miller, R, Bertelsmann, FW, Strijers, RLM, Boulton, A, Schady, W, Carrington, A, Brunet, D, Carter, W, Nickols, J, Rudnicki, S, Charles, A, Starr, A, Zhu, Y, Clarke, D, Smith, D, Cwik, V, DeCherney, S, Fisher, R, Dippe, S, Goodell, R, Dupre, J, Hramiak, I, Fox, CJV, Bissessar, A, Freeman, R, Godin, C, Lamontagne, A, Goldberg, R, Sharma, K, Kato, M, Greene, DA, Feldman, E, Grunberger, G, Selwa, JF, Harati, Y, Gooch, C, Kolimas, R, Hermansen, K, Christensen, J, Nielson, V, Hilsted, J, Damholt, M, Blatt, LB, Ipp, I, Anderson, T, Jennings, P, Laljee, CK, Jervell, J, Jorum, E, Ganes, T, Kennedy, F, Litchy, W, Kilo, C, Frere, R, Green, B, King, G, Rosenszweig, J, Herzog, A, Koivisto, V, Seppalainen, AM, Lau, D, Bourque, P, Preston, D, Levin, S, Chrissian, SA, MacCuish, A, Jamal, P, Malone, JI, Korthals, J, Olansky, L, Shipley, WD, Pfeifer, M, Farquhar, J, Pillay, N, Porte, D, Poticha, G, Gulevich, S, Raskin, P, Greenlee, R, Rayman, G, Wroe, SJ, Rosenstock, J, Gul, F, Saudek, C, Cornblath, D & Scarpello, J 1998, 'Electrophysiological monitoring in clinical trials', Muscle and Nerve, vol. 21, no. 11, pp. 1368-1373. https://doi.org/10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7
Bril, V. ; Ellison, R. ; Ngo, M. ; Bergstrom, B. ; Raynard, D. ; Gin, H. ; Belanger, A. ; Cote, L. ; Benstead, T. ; Heffernan, L. P. ; Bergenstal, R. ; Taylor, F. ; Bernstein, R. ; Miller, R. ; Bertelsmann, F. W. ; Strijers, R. L M ; Boulton, A. ; Schady, W. ; Carrington, A. ; Brunet, D. ; Carter, W. ; Nickols, J. ; Rudnicki, S. ; Charles, A. ; Starr, A. ; Zhu, Y. ; Clarke, D. ; Smith, D. ; Cwik, V. ; DeCherney, S. ; Fisher, R. ; Dippe, S. ; Goodell, R. ; Dupre, J. ; Hramiak, I. ; Fox, C. J V ; Bissessar, A. ; Freeman, R. ; Godin, C. ; Lamontagne, A. ; Goldberg, R. ; Sharma, K. ; Kato, M. ; Greene, D. A. ; Feldman, E. ; Grunberger, G. ; Selwa, J. F. ; Harati, Y. ; Gooch, C. ; Kolimas, R. ; Hermansen, K. ; Christensen, J. ; Nielson, V. ; Hilsted, J. ; Damholt, M. ; Blatt, L. B. ; Ipp, I. ; Anderson, T. ; Jennings, P. ; Laljee, C. K. ; Jervell, J. ; Jorum, E. ; Ganes, T. ; Kennedy, F. ; Litchy, W. ; Kilo, C. ; Frere, R. ; Green, B. ; King, G. ; Rosenszweig, J. ; Herzog, A. ; Koivisto, V. ; Seppalainen, A. M. ; Lau, D. ; Bourque, P. ; Preston, D. ; Levin, S. ; Chrissian, S. A. ; MacCuish, A. ; Jamal, P. ; Malone, J. I. ; Korthals, J. ; Olansky, L. ; Shipley, W. D. ; Pfeifer, M. ; Farquhar, J. ; Pillay, N. ; Porte, D. ; Poticha, G. ; Gulevich, S. ; Raskin, P. ; Greenlee, R. ; Rayman, G. ; Wroe, S. J. ; Rosenstock, J. ; Gul, F. ; Saudek, C. ; Cornblath, David ; Scarpello, J. / Electrophysiological monitoring in clinical trials. In: Muscle and Nerve. 1998 ; Vol. 21, No. 11. pp. 1368-1373.
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TY - JOUR

T1 - Electrophysiological monitoring in clinical trials

AU - Bril, V.

AU - Ellison, R.

AU - Ngo, M.

AU - Bergstrom, B.

AU - Raynard, D.

AU - Gin, H.

AU - Belanger, A.

AU - Cote, L.

AU - Benstead, T.

AU - Heffernan, L. P.

AU - Bergenstal, R.

AU - Taylor, F.

AU - Bernstein, R.

AU - Miller, R.

AU - Bertelsmann, F. W.

AU - Strijers, R. L M

AU - Boulton, A.

AU - Schady, W.

AU - Carrington, A.

AU - Brunet, D.

AU - Carter, W.

AU - Nickols, J.

AU - Rudnicki, S.

AU - Charles, A.

AU - Starr, A.

AU - Zhu, Y.

AU - Clarke, D.

AU - Smith, D.

AU - Cwik, V.

AU - DeCherney, S.

AU - Fisher, R.

AU - Dippe, S.

AU - Goodell, R.

AU - Dupre, J.

AU - Hramiak, I.

AU - Fox, C. J V

AU - Bissessar, A.

AU - Freeman, R.

AU - Godin, C.

AU - Lamontagne, A.

AU - Goldberg, R.

AU - Sharma, K.

AU - Kato, M.

AU - Greene, D. A.

AU - Feldman, E.

AU - Grunberger, G.

AU - Selwa, J. F.

AU - Harati, Y.

AU - Gooch, C.

AU - Kolimas, R.

AU - Hermansen, K.

AU - Christensen, J.

AU - Nielson, V.

AU - Hilsted, J.

AU - Damholt, M.

AU - Blatt, L. B.

AU - Ipp, I.

AU - Anderson, T.

AU - Jennings, P.

AU - Laljee, C. K.

AU - Jervell, J.

AU - Jorum, E.

AU - Ganes, T.

AU - Kennedy, F.

AU - Litchy, W.

AU - Kilo, C.

AU - Frere, R.

AU - Green, B.

AU - King, G.

AU - Rosenszweig, J.

AU - Herzog, A.

AU - Koivisto, V.

AU - Seppalainen, A. M.

AU - Lau, D.

AU - Bourque, P.

AU - Preston, D.

AU - Levin, S.

AU - Chrissian, S. A.

AU - MacCuish, A.

AU - Jamal, P.

AU - Malone, J. I.

AU - Korthals, J.

AU - Olansky, L.

AU - Shipley, W. D.

AU - Pfeifer, M.

AU - Farquhar, J.

AU - Pillay, N.

AU - Porte, D.

AU - Poticha, G.

AU - Gulevich, S.

AU - Raskin, P.

AU - Greenlee, R.

AU - Rayman, G.

AU - Wroe, S. J.

AU - Rosenstock, J.

AU - Gul, F.

AU - Saudek, C.

AU - Cornblath, David

AU - Scarpello, J.

PY - 1998

Y1 - 1998

N2 - 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.

AB - 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.

KW - Clinical trials

KW - Diabetic neuropathy

KW - Electrophysiology

KW - Monitoring laboratory

KW - Nerve conduction studies

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SN - 0148-639X

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