Study to Validate Novel Seizure-Detection Algorithm

NCT04291716 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-03-02

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Bracane Company

    collaborator INDUSTRY
  • Overwatch Digital Health

    lead INDUSTRY

Principal Investigators

  • Haytham Elgammal, MD · Overwatch Digital Health

  • Subha Sarcar, PhD · Bracane Company

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2020-10-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291716 on ClinicalTrials.gov