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| Name | Class |
|---|---|
| Bracane Company | INDUSTRY |
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The specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (Motor Seizure Detection Algorithm [mSDA]) installed on a wearable device to be worn by the subject. The software will be tested using subjects from a patient population in an epilepsy monitoring unit (EMU) undergoing video and electroencephalograph (VEEG) observation. The number of generalized major motor seizures detected by the mSDA will be compared with those detected by VEEG.
Seizures are paroxysmal, abnormal behaviors which usually are associated with altered awareness and amnesia. The frequency of seizures is not easily documented. The individual who suffers from seizures may be unaware that a seizure is occurring. Many seizures, including generalized major motor seizures, have stereotyped, vigorous motor activity associated with the events.
Currently, accurate seizure detection relies on EEG and video which are limited by time, size and mobility. Seizure detection can also use biomarkers such as movement patterns described by gyroscopes. These devices can monitor patterns of movement which correspond to the activity during seizures and kept in a log of seizures without patient input. The log can be used to notify patients or caregivers of seizures.
This study is to determine the accuracy of a system using a commercial, wearable device linked to a computer algorithm based in the cloud which stores the movement pattern and notifies the patient and others of a generalized major motor seizure. The accuracy will be determined by a comparison of the system detections to simultaneously recorded video electroencephalogram, considered the "gold standard" of seizure detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | This is a single-arm study. All subjects enrolled in the study will wear the device during stay in the EMU. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor Seizure Detection Algorithm (mSDA) | Device | A seizure detection algorithm installed on a propriety mobile application to be used on a commercially available watch with a gyroscope to detect movement. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Number of major motor seizure detections by algorithm with detection by video encephalogram data. | 1 to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| False positive rate | Total number of false positives and number of false positives per day. | 1 to 5 days |
| Mean detection latency | Time between algorithm detection and application notification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chis Czura, PhD | Contact | 214-662-7322 | chris.czura@overwatchdh.com | |
| Pamela J Nelson, PhD | Contact | 469.814.0658 | pjnelson@bracaneco.com |
| Name | Affiliation | Role |
|---|---|---|
| Haytham Elgammal, MD | Overwatch Digital Health | Principal Investigator |
| Subha Sarcar, PhD | Bracane Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covenant Hospital and Covenant Medical Group | Lubbock | Texas | 79410 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28276060 | Background | Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8. | |
| 6790275 |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a single cohort of subjects male or female, aged 18 and above who are epilepsy patients who have been admitted to an epilepsy monitoring unit (EMU).
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| 1 to 5 days |
| Notifications | Total number of seizure notifications received on subject's assigned email | 1 to 5 days |
| Cancellations | Total number of cancellations of false positive alerts made by the subject. | 1 to 5 days |
| Background |
| Proposal for revised clinical and electroencephalographic classification of epileptic seizures. From the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1981 Aug;22(4):489-501. doi: 10.1111/j.1528-1157.1981.tb06159.x. No abstract available. |
| 21221012 | Background | Kramer U, Kipervasser S, Shlitner A, Kuzniecky R. A novel portable seizure detection alarm system: preliminary results. J Clin Neurophysiol. 2011 Feb;28(1):36-8. doi: 10.1097/WNP.0b013e3182051320. |
| 31150998 | Background | Janse SA, Dumanis SB, Huwig T, Hyman S, Fureman BE, Bridges JFP. Patient and caregiver preferences for the potential benefits and risks of a seizure forecasting device: A best-worst scaling. Epilepsy Behav. 2019 Jul;96:183-191. doi: 10.1016/j.yebeh.2019.04.018. Epub 2019 May 29. |
| 30348268 | Background | Jalloul N. Wearable sensors for the monitoring of movement disorders. Biomed J. 2018 Aug;41(4):249-253. doi: 10.1016/j.bj.2018.06.003. Epub 2018 Sep 11. |
| 20930036 | Background | Muennig PA, Glied SA. What changes in survival rates tell us about us health care. Health Aff (Millwood). 2010 Nov;29(11):2105-13. doi: 10.1377/hlthaff.2010.0073. Epub 2010 Oct 7. |
| 29427026 | Background | Johansson D, Malmgren K, Alt Murphy M. Wearable sensors for clinical applications in epilepsy, Parkinson's disease, and stroke: a mixed-methods systematic review. J Neurol. 2018 Aug;265(8):1740-1752. doi: 10.1007/s00415-018-8786-y. Epub 2018 Feb 9. |
| 15975855 | Background | Nijsen TM, Arends JB, Griep PA, Cluitmans PJ. The potential value of three-dimensional accelerometry for detection of motor seizures in severe epilepsy. Epilepsy Behav. 2005 Aug;7(1):74-84. doi: 10.1016/j.yebeh.2005.04.011. |
| 25928634 | Background | Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015. |
| 23398578 | Background | Beniczky S, Polster T, Kjaer TW, Hjalgrim H. Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: a prospective, multicenter study. Epilepsia. 2013 Apr;54(4):e58-61. doi: 10.1111/epi.12120. Epub 2013 Feb 8. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |