NCT03283748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

February 24, 2021

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

September 8, 2017

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • Digital Signal processing of the data

    3 months

Study Arms (1)

Measurement of Motor Movements

EXPERIMENTAL

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.

Device: Wearable sensors

Interventions

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

Measurement of Motor Movements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subject has seizures or symptoms of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mini Thomas

Hamilton, Ontario, L9C 0E5, Canada

Location

Related Links

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mini Thomas, M.Eng.

    Mohawk College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 14, 2017

Study Start

November 1, 2017

Primary Completion

February 25, 2018

Study Completion

January 30, 2019

Last Updated

February 24, 2021

Record last verified: 2018-03

Locations