A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position
Brigham and Women's Hospital
Summary
The goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress. Primary Objective Milestones: Feasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS. Secondary Objective Detect the postictal prone position with an accuracy of 100%.
Description
This is an exploratory study with the goal of using a commercial bed sheet sensor and software with Soterya Inc's Korus software to identify GTCs in an inpatient setting. 50 patients will be monitored at the BWH EMU with the goal of capturing 20 GTCS events. The sheet sensor used will be the Sensor Products Tactilus High Performance Mattress Sensor System with the accompanying Tactilus Software. Pressure sensor data will be processed by Soterya Inc's Korus Software. The sensor system is a piezoresistive device that is already in commercial use.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1\. Adults 18 years of age or older admitted to the BWH EMU with drug-resistant epilepsy, defined by the failure of at least two anti-seizure medications and a documented history of electroclinical seizures Exclusion criteria: 1. Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures) 2. Patients admitted for medication adjustment only
Interventions
- DeviceStudy Subjects
The subject will be monitored as they lie on the Tactilus Bodyfitter sensor.
Location
- Brigham and Women's HospitalBoston, Massachusetts