Detection of generalized tonic–clonic seizures using surface electromyographic monitoring

• Type of Material: Article
• Authors: Jonathan J. Halford, Medical University of South Carolina; Michael R. Sperling, Thomas Jefferson University Hospital; Dileep R. Nair, Cleveland Clinic Foundation; Dennis J. Dlugos, The Children's Hospital of Philadelphia; William O. Tatum, Mayo Clinic in Jacksonville, Florida; Jay Harvey, UT Southwestern Medical School; Jacqueline A. French, NYU Langone Medical Center; John R. Pollard, University of Pennsylvania; Raymond Faught Jr, Emory University; Katherine H. Noe, Mayo Clinic Scottsdale-Phoenix, Arizona; Thomas R. Henry, Fairview Health Service; Gina M. Jetter, Northeast Texas Neurology Associates; Octavian V. Lie, University of Texas Health Science Center at San Antonio; Lola C. Morgan, University of Texas Health Science Center at San Antonio; Michael R. Girouard, Brain Sentinel Inc.; Damon P. Cardenas, Brain Sentinel Inc.; Luke E. Whitmire, Brain Sentinel Inc.; Jose E. Cavazos, Brain Sentinel Inc.
• Language: English
• Date: 2017-11-01
• Publisher: Wiley: 12 months
• Publication Version: Final Published Version
• Copyright Statement: © 2017 The Authors.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1111/epi.13897
• Title of Journal or Parent Work: Epilepsia
• ISSN: 0013-9580
• Volume: 58
• Issue: 11
• Start Page: 1861
• End Page: 1869
• Grant/Funding Information: This study was funded by Brain Sentinel in San Antonio, Texas.
• Research Categories: Biology, Neuroscience; Biology, General

Abstract

Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy. Objective: A prospective multicenter phase III trial was undertaken to evaluate the performance and tolerability in the epilepsy monitoring unit (EMU) of an investigational wearable surface electromyographic (sEMG) monitoring system for the detection of generalized tonic–clonic seizures (GTCSs). Methods: One hundred ninety-nine patients with a history of GTCSs who were admitted to the EMU in 11 level IV epilepsy centers for clinically indicated video-electroencephalographic monitoring also received sEMG monitoring with a wearable device that was worn on the arm over the biceps muscle. All recorded sEMG data were processed at a central site using a previously developed detection algorithm. Detected GTCSs were compared to events verified by a majority of three expert reviewers. Results: For all subjects, the detection algorithm detected 35 of 46 (76%, 95% confidence interval [CI] = 0.61–0.87) of the GTCSs, with a positive predictive value (PPV) of 0.03 and a mean false alarm rate (FAR) of 2.52 per 24 h. For data recorded while the device was placed over the midline of the biceps muscle, the system detected 29 of 29 GTCSs (100%, 95% CI = 0.88–1.00), with a detection delay averaging 7.70 s, a PPV of 6.2%, and a mean FAR of 1.44 per 24 h. Mild to moderate adverse events were reported in 28% (55 of 199) of subjects and led to study withdrawal in 9% (17 of 199). These adverse events consisted mostly of skin irritation caused by the electrode patch that resolved without treatment. No serious adverse events were reported. Significance: Detection of GTCSs using an sEMG monitoring device on the biceps is feasible. Proper positioning of this device is important for accuracy, and for some patients, minimizing the number of false positives may be challenging.