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. Brunet; W. 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; Philip Raskin; R. Greenlee; G. Rayman; S. J. Wroe; J. Rosenstock; F. Gul; C. Saudek; D. Cornblath; J. Scarpello

doi:10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7

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, Philip Raskin, R. Greenlee, G. Rayman, S. J. Wroe, J. Rosenstock, F. Gul, C. Saudek, D. Cornblath, J. Scarpello

Research output: Contribution to journal › Article › peer-review

90 Scopus citations

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 language	English (US)
Pages (from-to)	1368-1373
Number of pages	6
Journal	Muscle and Nerve
Volume	21
Issue number	11
DOIs	https://doi.org/10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7
State	Published - 1998

Keywords

Clinical trials
Diabetic neuropathy
Electrophysiology
Monitoring laboratory
Nerve conduction studies

ASJC Scopus subject areas

Physiology
Clinical Neurology
Cellular and Molecular Neuroscience
Physiology (medical)

Access to Document

10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7

Cite this

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., ... 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

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

@article{d3978e151f4d4d73abe84718d44c4f8b,

title = "Electrophysiological monitoring in clinical trials",

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.",

keywords = "Clinical trials, Diabetic neuropathy, Electrophysiology, Monitoring laboratory, Nerve conduction studies",

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

year = "1998",

doi = "10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7",

language = "English (US)",

volume = "21",

pages = "1368--1373",

journal = "Muscle and Nerve",

issn = "0148-639X",

publisher = "John Wiley and Sons Inc.",

number = "11",

}

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, Philip

AU - Greenlee, R.

AU - Rayman, G.

AU - Wroe, S. J.

AU - Rosenstock, J.

AU - Gul, F.

AU - Saudek, C.

AU - Cornblath, D.

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

UR - http://www.scopus.com/inward/record.url?scp=0031717090&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031717090&partnerID=8YFLogxK

U2 - 10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7

DO - 10.1002/(SICI)1097-4598(199811)21:11<1368::AID-MUS2>3.0.CO;2-7

M3 - Article

C2 - 9771658

AN - SCOPUS:0031717090

SN - 0148-639X

VL - 21

SP - 1368

EP - 1373

JO - Muscle and Nerve

JF - Muscle and Nerve

IS - 11

ER -

Electrophysiological monitoring in clinical trials

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this