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Detection of Motor Seizures Using WBAN (DMS-WBAN)

Primary Purpose

Seizures, Tonic-Clonic

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Wearable sensors

About this trial

This is an interventional diagnostic trial for Seizures, Tonic-Clonic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

subject has seizures or symptoms of seizures

Exclusion Criteria:

Sites / Locations

Mini Thomas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Measurement of Motor Movements

Arm Description

Wearable Accelerometer Sensors manufactured by leading manufacturers will be given to the participants to be worn around hands and legs. These sensors will be used to measure accelerations which will be impacted by the motor movements.

Outcomes

Primary Outcome Measures

Measurement of Acceleration

Motor movements will cause changes in acceleration. Accelerometer sensors will be used to measure the acceleration as a first step towards detection of Tonic Clonic Seizures

Secondary Outcome Measures

Digital Signal processing of the data

The raw acceleration data collected will be processed in a computer with MATLAB software using Digital Signal processing techniques. These techniques will help identify the data and differentiate the seizure movements from normal movements thereby helping to detect seizures data

Full Information

NCT ID

NCT03283748

First Posted

September 8, 2017

Last Updated

February 23, 2021

Sponsor

Mohawk College

Collaborators

Hamilton Health Sciences Corporation, Toronto Metropolitan University

1. Study Identification

Unique Protocol Identification Number

NCT03283748

Brief Title

Detection of Motor Seizures Using WBAN

Acronym

DMS-WBAN

Official Title

Detection of Motor Seizures Using Wireless Body Area Network

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

February 25, 2018 (Actual)

Study Completion Date

January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mohawk College

Collaborators

Hamilton Health Sciences Corporation, Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to collect the motor movement data using sensors to detect Generalized Tonic Clonic Seizures . Wearable sensors similar to smart watches will be used to detect seizures. The proposed system will consist of 3-4 wearable wireless sensor worn on the hands and legs. The data from these sensors will be send to the clod and collected to a central hub for analysis and detection of GTC Seizures.

Detailed Description

The key of the project is digital signal processing of the movement data collected. The medical application sensors from Analog Devices will be worn around the wrist and legs of the participants. These sensors will continuously collect the motor movement data. The data will be send to the cloud from where it will be collected at a central hub for digital signal processing and detection. The data analysis results will be compared with the standard EEG results for Tonic Clonic seizures and results will be verified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seizures, Tonic-Clonic

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Measurement of Motor Movements

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Wearable sensors

Intervention Description

Wearable sensors will be given to the participants to be worn and movement data will be collected

Primary Outcome Measure Information:

Title

Measurement of Acceleration

Description

Motor movements will cause changes in acceleration. Accelerometer sensors will be used to measure the acceleration as a first step towards detection of Tonic Clonic Seizures

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Digital Signal processing of the data

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: subject has seizures or symptoms of seizures Exclusion Criteria:

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mini Thomas, M.Eng.

Organizational Affiliation

Mohawk College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mini Thomas

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L9C 0E5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/26926071

Description

Non-EEG based ambulatory seizure detection designed for home use: What is available and how will it influence epilepsy care?

URL

https://www.ncbi.nlm.nih.gov/pubmed/26190150

Description

Electromyography-based seizure detector: Preliminary results comparing a generalized tonic-clonic seizure detection algorithm to video-EEG recordings

URL

https://www.ncbi.nlm.nih.gov/pubmed/26859097

Description

Safe and sound? A systematic literature review of seizure detection methods for personal useSafe and sound? A systematic literature review of seizure detection methods for personal use

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Detection of Motor Seizures Using WBAN

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