Epilepsy
Conditions
Brief 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%.
Detailed 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.
Interventions
DEVICEStudy Subjects
The subject will be monitored as they lie on the Tactilus Bodyfitter sensor.
Sponsors
Brigham and Women's Hospital
Soterya Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body position detection | 5 seconds | Correct detection of one of 4 cardinal body positions: prone, supine, left, right |
| Number of subjects correctly repositioned from the prone to recovery position | 30 seconds | We will measure the performance of Korus to successfully reposition the subject from the prone to recovery position |
Countries
United States
Contacts
CONTACTJong Woo Lee, MD, PhD
PRINCIPAL_INVESTIGATORJong Woo Lee, MD, PhD
Brigham and Women's Hospital
Outcome results
None listed