Study to Validate Novel Seizure-Detection Algorithm

February 27, 2020 updated by: Overwatch Digital Health

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79410
        • Covenant Hospital and Covenant Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Meets the standard of care criteria for admission to an epilepsy monitoring unit (EMU).
  4. Male or female.
  5. Aged 18 and above.
  6. The patient has experienced at least one generalized major motor seizure prior to admission.
  7. Agreement to wear a wristwatch throughout the duration of the study on the left wrist.
  8. Ability to cancel false positive alarms via interaction with the application on the watch.

Exclusion Criteria:

  1. Concurrent physiological diseases with movement disorders (Parkinson's, tremor, ataxia, Huntington's, paralysis of the upper body, pseudo-seizures).
  2. Known allergic reactions to components of the (watch materials).
  3. Treatment with another investigational drug or other intervention within the study
  4. Children under the age of 18.
  5. Women who are pregnant or nursing.
  6. Inability to give consent to the study.
  7. Active skin infection or rash on the upper extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
This is a single-arm study. All subjects enrolled in the study will wear the device during stay in the EMU.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 1 to 5 days
Number of major motor seizure detections by algorithm with detection by video encephalogram data.
1 to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
False positive rate
Time Frame: 1 to 5 days
Total number of false positives and number of false positives per day.
1 to 5 days
Mean detection latency
Time Frame: 1 to 5 days
Time between algorithm detection and application notification
1 to 5 days
Notifications
Time Frame: 1 to 5 days
Total number of seizure notifications received on subject's assigned email
1 to 5 days
Cancellations
Time Frame: 1 to 5 days
Total number of cancellations of false positive alerts made by the subject.
1 to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Overwatch Digital Health

Collaborators

Bracane Company

Investigators

  • Principal Investigator: Haytham Elgammal, MD, Overwatch Digital Health
  • Study Director: Subha Sarcar, PhD, Bracane Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OW012019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on Motor Seizure Detection Algorithm (mSDA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe