NCT04291716

Study to Validate Novel Seizure-Detection Algorithm

Validation of an Algorithm for Identification and Notification of Generalized Major Motor Seizures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Overwatch Digital Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Seizures, Motor
• Seizures
• Seizure Disorder
• Epilepsy
• Epileptic Seizures
• Epileptic

Interventions

Type	Name	Description
DEVICE	Motor Seizure Detection Algorithm (mSDA)	A seizure detection algorithm installed on a propriety mobile application to be used on a commercially available watch with a gyroscope to detect movement.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2020-03-02
• Last updated: 2020-03-02

Locations

1 site across 1 country: United States