Advanced search
Publication Cover
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Volume 19, 2018 - Issue 7-8
Submit an article Journal homepage
384
Views
31
CrossRef citations to date
0
Altmetric
Clinical Trial

Reducing sample size requirements for future ALS clinical trials with a dedicated electrical impedance myography system

Jeremy M. ShefnerDepartment of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA; Correspondence[email protected]
View further author information
,
Seward B. RutkoveDepartment of Neurology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA; View further author information
,
James B. CaressDepartment of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA; View further author information
,
Michael BenatarDepartment of Neurology, University of Miami, Miami, FL, USA; View further author information
,
William S. DavidDepartment of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; View further author information
,
Michael S. CartwrightDepartment of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA; View further author information
,
Eric A. MacklinBiostatistics Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; View further author information
&
Jose L. BohorquezMyolex, Inc, San Francisco, CA, USAView further author information
 show all
Pages 555-561 | Received 22 Feb 2018, Accepted 02 Jul 2018, Published online: 28 Sep 2018

References

  • Lacomblez L, Bensimon G, Leigh PN, Guillet P, Meininger V. Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis/Riluzole Study Group II. Lancet. 1996;347:1425–31.
  • Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999;169:13–21.
  • Berry JD, Miller R, Moore DH, Cudkowicz ME, Van Den Berg LH, Kerr DA, et al. The Combined Assessment of Function and Survival (CAFS): a new endpoint for ALS clinical trials. Amyotroph Lateral Scler Front Degener. 2013;14:162–8.
  • Benatar M, Boylan K, Jeromin A, Rutkove SB, Berry J, Atassi N, et al. ALS biomarkers for therapy development: state of the field and future directions. Muscle Nerve. 2016;53:169–82.
  • Rutkove SB. Electrical impedance myography: background, current state, and future directions. Muscle Nerve. 2009;40:936–46.
  • Rutkove SB, Zhang H, Schoenfeld DA, Raynor EM, Shefner JM, Cudkowicz ME, et al. Electrical impedance myography to assess outcome in amyotrophic lateral sclerosis clinical trials. Clin Neurophysiol. 2007;118:2413–8.
  • Rutkove SB, Caress JB, Cartwright MS, Burns TM, Warder J, David WS, et al. Electrical impedance myography as a biomarker to assess ALS progression. Amyotroph Lateral Scler. 2012;13:439–45.
  • Zaidman CM, Wang LL, Connolly AM, Florence J, Wong BL, Parsons JA, et al. Electrical impedance myography in Duchenne muscular dystrophy and healthy controls: a multicenter study of reliability and validity. Muscle Nerve. 2015;52:592–7.
  • Brooks BR, Miller RG, Swash M, Munsat TL. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000;1:293–9.
  • Andres PL, Finison LJ, Conlon T, Thibodeau LM, Munsat TL. Use of composite scores (megascores) to measure deficit in amyotrophic lateralsclerosis. Neurology. 1988;38:405–8.
  • Schwartz S, Geisbush TR, Mijailovic A, Pasternak A, Darras BT, Rutkove SB. Optimizing electrical impedance myography measurements by using a multifrequency ratio: a study in Duchenne muscular dystrophy. Clin Neurophysiol. 2015;126:202–8.
  • Jafarpoor M, Li J, White JK, Rutkove SB. Optimizing electrode configuration for electrical impedance measurements of muscle via the finite element method. IEEE Trans Biomed Eng. 2013;60:1446–52.
  • Cudkowicz ME, Titus S, Kearney M, Yu H, Sherman A, Schoenfeld D, et al. Safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis: a multi-stage, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014;13:1083–91.
  • Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, et al. Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2013;12:1059–67.
  • Andres PL, Skerry LM, Munsat TL, Thornell BJ, Szymonifka J, Schoenfeld DA, et al. Validation of a new strength measurement device for amyotrophic lateral sclerosis clinical trials. Muscle Nerve. 2012;45:81–5.
  • Wang LL, Spieker AJ, Li J, Rutkove SB. Electrical impedance myography for monitoring motor neuron loss in the SOD1 G93A amyotrophic lateral sclerosis rat. Clin Neurophysiol. 2011;122:2505–11.
  • Li J, Sung M, Rutkove SB. Electrophysiologic biomarkers for assessing disease progression and the effect of riluzole in SOD1 G93A ALS mice. PLoS One. 2013/06/14. 2013;8:e65976.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.