Detection of generalized tonic–clonic seizures using surface electromyographic monitoring

Jonathan J. Halford, Michael R. Sperling, Dileep R. Nair, Dennis J. Dlugos, William O. Tatum, Jay Harvey, Jacqueline A. French, John R. Pollard, Edward Faught, Katherine H. Noe, Thomas R. Henry, Gina M. Jetter, Octavian V. Lie, Lola C. Morgan, Michael R. Girouard, Damon P. Cardenas, Luke E. Whitmire, Jose E. Cavazos

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1861-1869
Number of pages9
JournalEpilepsia
Volume58
Issue number11
DOIs
StatePublished - Nov 1 2017

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Seizures
Epilepsy
Equipment and Supplies
Confidence Intervals
Muscles
Electrodes
Skin
Therapeutics

Keywords

  • Clinical trials
  • Convulsions
  • Epilepsy monitoring
  • Generalized seizures
  • Grand mal seizures
  • Wearables

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Halford, J. J., Sperling, M. R., Nair, D. R., Dlugos, D. J., Tatum, W. O., Harvey, J., ... Cavazos, J. E. (2017). Detection of generalized tonic–clonic seizures using surface electromyographic monitoring. Epilepsia, 58(11), 1861-1869. https://doi.org/10.1111/epi.13897

Detection of generalized tonic–clonic seizures using surface electromyographic monitoring. / Halford, Jonathan J.; Sperling, Michael R.; Nair, Dileep R.; Dlugos, Dennis J.; Tatum, William O.; Harvey, Jay; French, Jacqueline A.; Pollard, John R.; Faught, Edward; Noe, Katherine H.; Henry, Thomas R.; Jetter, Gina M.; Lie, Octavian V.; Morgan, Lola C.; Girouard, Michael R.; Cardenas, Damon P.; Whitmire, Luke E.; Cavazos, Jose E.

In: Epilepsia, Vol. 58, No. 11, 01.11.2017, p. 1861-1869.

Research output: Contribution to journalArticle

Halford, JJ, Sperling, MR, Nair, DR, Dlugos, DJ, Tatum, WO, Harvey, J, French, JA, Pollard, JR, Faught, E, Noe, KH, Henry, TR, Jetter, GM, Lie, OV, Morgan, LC, Girouard, MR, Cardenas, DP, Whitmire, LE & Cavazos, JE 2017, 'Detection of generalized tonic–clonic seizures using surface electromyographic monitoring', Epilepsia, vol. 58, no. 11, pp. 1861-1869. https://doi.org/10.1111/epi.13897
Halford, Jonathan J. ; Sperling, Michael R. ; Nair, Dileep R. ; Dlugos, Dennis J. ; Tatum, William O. ; Harvey, Jay ; French, Jacqueline A. ; Pollard, John R. ; Faught, Edward ; Noe, Katherine H. ; Henry, Thomas R. ; Jetter, Gina M. ; Lie, Octavian V. ; Morgan, Lola C. ; Girouard, Michael R. ; Cardenas, Damon P. ; Whitmire, Luke E. ; Cavazos, Jose E. / Detection of generalized tonic–clonic seizures using surface electromyographic monitoring. In: Epilepsia. 2017 ; Vol. 58, No. 11. pp. 1861-1869.
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