EpilepsyNCT02371200
Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
An observational study of Epilepsy and Generalized Tonic-Clonic Seizures, run by Brain Sentinel at 2 sites in United States.
Trial summary
Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures. 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
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Feb 2018
- 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: Children and Adults with 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.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- 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).
- 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.
- Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
- Intracranial EEG electrodes are being used
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University Hospital
San Antonio, Texas, 78229
About this study
Official title: A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System (System Version 1.5) in Epilepsy Patients
Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.
Read the detailed description
This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.
- 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
The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.
| Study group | Role | What they receive |
|---|---|---|
| Brain Sentinel Seizure Detection and Warning System | This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG. 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.
Sensitivity of the Seizure Detection System
The primary outcome measure for this clinical trial will be the sensitivity of the Brain Sentinel™ Seizure Detection Systems ability to detect GTC seizure activity in comparison to a Neurologist independent review of vEEG collected in an epilepsy monitoring unit.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionFeb 2018
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Szabo, MD, Principal investigator, University Health System of San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371200
- Sponsor's protocol ID
- GTC-1.5-09.2015
- Status last verified
- Jul 2018
- First submitted
- 13 Feb 2015
- Last updated
- 10 Jul 2018
- 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 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System (System Version 1.5) in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT02371200
- Acronym / sponsor ID
- GTC-1.5-09.2015
- Conditions
- Epilepsy, Generalized Tonic-Clonic Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Feb 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.
Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.
Detailed description
This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.
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 SystemThis study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and Adults with 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.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- 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).
- 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.
- Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
- Intracranial EEG electrodes are being used
- The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
- Pregnant female.
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 SystemThe detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. | Device | Brain Sentinel Seizure Detection and Warning System |
Primary outcome
Sensitivity of the Seizure Detection System
Time frame: up to 1 month
The primary outcome measure for this clinical trial will be the sensitivity of the Brain Sentinel™ Seizure Detection Systems ability to detect GTC seizure activity in comparison to a Neurologist independent review of vEEG collected in an epilepsy monitoring unit.
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 10 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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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.
Charles Szabo, MD principal investigator
University Health System of San Antonio
2 sites 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 2 sites 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sensitivity of the Seizure Detection System (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 10 Jul 2018.