EpilepsyNCT02555410
Seizure Detection and Warning System in Epilepsy Patients
An observational study of Epilepsy and Generalized Tonic-Clonic Seizures, run by Brain Sentinel at 1 site in United States.
Trial summary
This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home. Read more about this study
- Who is it for?
- Ages 2 to 99 years
- Conditions the study is for
- Epilepsy, Generalized Tonic-Clonic Seizures
- What is being tested?
- Brain Sentinel Seizure Detection and Warning System
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 7 Jul 2017
- Phase
- Observational
- 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 2 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization
Who may be able to join
- Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
- Male or female between the ages of 2-99.
- Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
- Be able to tolerate wearing the device on the upper arm.
- If female and of childbearing potential, has a negative pregnancy test.
- Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
- Subject and/or Primary Caregiver must be competent to follow all study procedures.
- Is able to read, speak and understand English.
Who cannot join
- Does not have a documented history of generalized seizures.
- The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm)
- Pregnant female
- Subject/Caregiver is unable to provide consent.
- Subject/Caregiver is not competent to follow home study procedures.
- The subject is homeless or in a home without a power supply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal, Phase II Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
Read the detailed description
The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.
- Conditions
- Epilepsy, Generalized Tonic-Clonic Seizures
- Being tested
- Brain Sentinel Seizure Detection and Warning System
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Sentinel Seizure Detection and Warning SystemDevice
Also called SPEAC System
A sEMG based automated seizure detection and warning system worn on the biceps
| Study group | Role | What they receive |
|---|---|---|
| Brain Sentinel Seizure Detection and Warning System | To test the usability of the Brain Sentinel Seizure Detection and Warning System(also known as the SPEAC system) in a patient home setting. Receives: Device: Brain Sentinel Seizure Detection and Warning System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions.
The overall usability and technical features will be assessed through questionnaires and surveys as the Seizure Detection and Warning System will be used within a home setting.
Measured: up to 1 month
Secondary outcomes (1)
Compare the accuracy of the EMG based system's log to the subject's seizure diary
Comparison of the subject's seizure diary to the EMG based seizure detection system's seizure logs will help determine overall function.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startJan 2013
- Primary completion7 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose E. Cavazos, MD, PhD, Principal investigator, Brain Sentinel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555410
- Sponsor's protocol ID
- 3.01P
- Status last verified
- Jul 2017
- First submitted
- 13 Feb 2015
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Phase II Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT02555410
- Acronym / sponsor ID
- 3.01P
- Conditions
- Epilepsy, Generalized Tonic-Clonic Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 21 Sep 2015 (estimated)
- 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 is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
Detailed description
The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Sentinel Seizure Detection and Warning System | – | Device: Brain Sentinel Seizure Detection and Warning SystemTo test the usability of the Brain Sentinel Seizure Detection and Warning System(also known as the SPEAC system) in a patient home setting. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization
Key inclusion criteria (8 listed)
- Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
- Male or female between the ages of 2-99.
- Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
- Be able to tolerate wearing the device on the upper arm.
- If female and of childbearing potential, has a negative pregnancy test.
Key exclusion criteria (6 listed)
- Does not have a documented history of generalized seizures.
- The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm)
- Pregnant female
- Subject/Caregiver is unable to provide consent.
- Subject/Caregiver is not competent to follow home study procedures.
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 |
|---|---|---|
| Brain Sentinel Seizure Detection and Warning SystemAlso: SPEAC SystemA sEMG based automated seizure detection and warning system worn on the biceps | Device | Brain Sentinel Seizure Detection and Warning System |
Primary outcome
Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions.
Time frame: up to 1 month
The overall usability and technical features will be assessed through questionnaires and surveys as the Seizure Detection and Warning System will be used within a home setting.
1 secondary outcome
Compare the accuracy of the EMG based system's log to the subject's seizure diary
Time frame: up to one month
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 12 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Jose E. Cavazos, MD, PhD principal investigator
Brain Sentinel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Generalized Tonic-Clonic Seizures, run by Brain Sentinel at 1 site in United States.
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 8 inclusion and 6 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 12 Jul 2017. 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 United States. 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?
Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions. (time frame: up to 1 month). 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 12 Jul 2017.