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NCT06135285
A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position
Conditions: Epilepsy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
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%.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06135285). StuddyBuddy aggregates publicly available trial information.
