Seizures, Tonic-ClonicDMS-WBANNCT03283748
Detection of Motor Seizures Using WBAN
A study testing Wearable sensors in people with Seizures, Tonic-Clonic, run by Mohawk College at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seizures, Tonic-Clonic
- What is being tested?
- Wearable sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject has seizures or symptoms of seizures
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Motor Seizures Using Wireless Body Area Network
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.
Read the 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.
- Conditions
- Seizures, Tonic-Clonic
- Being tested
- Wearable sensors
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable sensorsDevice
Wearable sensors will be given to the participants to be worn and movement data will be collected
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Wearable sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Nov 2017
- Primary completion25 Feb 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seizures, Tonic-ClonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohawk College
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Toronto Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Mini Thomas, M.Eng., Principal investigator, Mohawk College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283748
- Sponsor's protocol ID
- 3596
- Acronym
- DMS-WBAN
- Status last verified
- Mar 2018
- First submitted
- 8 Sep 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Motor Seizures Using Wireless Body Area Network
- ClinicalTrials.gov ID
- NCT03283748
- Acronym / sponsor ID
- DMS-WBAN / 3596
- Conditions
- Seizures, Tonic-Clonic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mohawk CollegeUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Toronto Metropolitan University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 25 Feb 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement of Motor Movements | Experimental | Device: Wearable sensorsWearable 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subject has seizures or symptoms of seizures
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable sensorsWearable sensors will be given to the participants to be worn and movement data will be collected | Device | Measurement of Motor Movements |
Primary outcome
Measurement of Acceleration
Time frame: 3 months
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
1 secondary outcome
Digital Signal processing of the data
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Non-EEG based ambulatory seizure detection designed for home use: What is available and how will it influence epilepsy care?Link provided by the sponsor.
- Electromyography-based seizure detector: Preliminary results comparing a generalized tonic-clonic seizure detection algorithm to video-EEG recordingsLink provided by the sponsor.
- 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 useLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mini Thomas, M.Eng. principal investigator
Mohawk College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable sensors in people with Seizures, Tonic-Clonic, run by Mohawk College at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Acceleration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.