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.
Bibliographical noteFunding Information:
A custom-designed device for recording sEMG data was used (Fig. S1) that includes a commercial foam-backed electrode patch containing three pregelled, Ag/AgCl surface electrodes (1-cm diameter and 1 cm apart in a triangular configuration; Multi Bio Sensors, El Paso, TX, U.S.A.). Recording electrodes were placed transversely over the belly of the biceps brachii muscle with the reference electrode oriented proximally. The electrode patch adhered to the skin with an acrylic-based adhesive, and the weight of the device was supported by an arm band. The electrical components of the applied device consist of an instrumentation amplifier, filtering network, and microcontroller designed to amplify and continuously record 1-kHz sampled sEMG, analyze sEMG for potential seizure activity, and transmit potential seizure alerts via Wi-Fi to a base station (BSN) computer. See Figure S1 for an example of the sEMG signal recorded from a GTCS.
This study was funded by Brain Sentinel in San Antonio, Texas.
Jonathan J. Halford has acted as a consultant for Brain Sentinel, Acorda, Eisai Medical Research, UCB Pharma, Lundbeck, Validus Pharmaceuticals, SK Life Sciences, and Upsher-Smith; receives funding from the National Institutes of Health (NIH; SBIR-IIB-2R44NS064647-05A1); and has been an investigator for clinical trials funded by Acorda, Eisai, LCGH, GW Pharma, Lundbeck, Optima Neurosciences, UCB, and the Epilepsy Study Consortium. Michael R. Sperling has acted as a consultant for Med-tronic (for protocol design, contract with Thomas Jefferson University; payment to Thomas Jefferson University) and Medscape (for continuing medical education activity); receives research funding from UCB Pharma, Sunovion, SK Life Sciences, Eisai, Pfizer, Glaxo, Accorda, Upsher-Smith, Neurelis, Marinus, Lundbeck, Brain Sentinel, and Medtronic; and has research contracts with Thomas Jefferson University, UCB Pharma, Suno-vion, SK Life Sciences, Eisai, Pfizer, Glaxo, Acorda, Upsher-Smith, Neure-lis, Marinus, Lundbeck, Brain Sentinel, and Medtronic. Dileep R. Nair receives funding from the NIH (RNS089212A_A7886P1), Brain Sentinel, and Neuropace. Dennis J. Dlugos receives funding from the NIH (1R01NS053998, 2U01NS045911, U01NS077276) and the Epilepsy Study Consortium. William O. Tatum receives a stipend from Elsevier as Editor-in-Chief of Epilepsy & Behavior Case Reports, royalties from Demos Medical Publishing and Springer Publishing, and grant support from Mayo Clinic; and has acted as a consultant for SK Life Science (safety board). Jay Harvey has acted as a consultant for UCB and Sunovion; and receives funding (as an investigator) for clinical trials by Acorda, SK Life, GW Pharma, UCB, Sage, and Marinus. Jacqueline A. French receives New York University (NYU) salary support for consulting work on behalf of the Epilepsy Study Consortium from Acorda, Adamas, Alexza, Anavex, Axcella Health, Biogen, BioPharm Solutions, Cerecor, Concert Pharmaceuticals, Eisai, Georgia Regents University, GlaxoSmithKline, GW Pharma, Marinus, Monteris, NestléHealth Science, Neurelis, Novartis, Pfizer, Pfizer-Neusen-tis, Roivant, Sage, SciFluor, SK Life Sciences, Sunovion, Takeda, UCB, Upsher-Smith, Xenon Pharmaceuticals, Zogenix, and Zynerba; has received personal compensation for serving as an Associate Editor of Epilepsia; and has received research grants from Acorda, Alexza, Eisai Medical Research, LCGH, Lundbeck, Pfizer, SK Life Sciences, Sunovion, UCB, Upsher-Smith, and Vertex, as well as grants from the Epilepsy Research Foundation, Epilepsy Study Consortium, Epilepsy Therapy Project, and National Institute of Neurological Disorders and Stroke; is on the editorial board of Lancet Neurology, Neurology Today, and Epileptic Disorders; is scientific officer for the Epilepsy Foundation, for which NYU receives salary support; and has received travel reimbursement related to research, advisory meetings, or presentation of results at scientific meetings from the Epilepsy Study Consortium, the Epilepsy Foundation, Eisai, GW Pharma, Marinus, NestléLife Sciences, Pfizer, Sage, SK Life Sciences, Takeda, UCB, Upsher-Smith, Zogenix, and Zynerba. John R. Pollard is part owner of Cognizance Biomarkers; and receives research support from GlaxoSmithKline, Cognizance Biomarkers, and SK Pharmaceuticals. Edward Faught has received consulting fees from Aprecia, Biogen, Eisai, Medscape, and UCB Pharma; has served on research data monitoring boards for Eisai, Lundbeck, Sage, and SK Life Science; and has received research funding from Brain Sentinel and UCB Pharma. Katherine H. Noe receives research funding from Neuropace. Thomas R. Henry receives research funding from the NIH (1U01NS088034-01, NS-058634-01A2), the National Science Foundation (CRCNS 15-595, award 1607835), the Centers for Disease Control and Prevention (subproject 00047299 of 1U48-DP005022-01), and Brain Sentinel. Gina M. Jetter and Octavian V. Lie have acted as consultants for Brain Sentinel. Lola C. Morgan receives funding from UCB, Upsher-Smith, and Sage Pharmaceuticals. Michael R. Gir-ouard owns stock in and is employed by Brain Sentinel. Damon P. Cardenas and Luke E.Whitmire are employees of Brain Sentinel. Jose E. Cavazos owns stock in and is a consultant to Brain Sentinel. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.
- Clinical trials
- Epilepsy monitoring
- Generalized seizures
- Grand mal seizures