EpilepsyNCT01874600
Seizure Detection and Warning System for Epilepsy Patients
An observational study of Epilepsy, run by Brain Sentinel at 1 site in United States.
Trial summary
The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brain Sentinel Seizure Detection Device and Warning System
- Type of treatment
- Medical device
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2019
- 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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescent epilepsy patients with a history of generalized tonic-clonic seizures either primary GTC or partial onset seizures with second generalization.
Who may be able to join
- Subject has a suspected 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 13-21.
- If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
- 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 or has a LAR that does so.
- Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.
Who cannot join
- 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 is allergic to adhesives or any component of the electrode patch assembly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.
- Conditions
- Epilepsy
- Being tested
- Brain Sentinel Seizure Detection Device and Warning System
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Sentinel Seizure Detection Device and Warning SystemDevice
The Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy Patients | 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 Device and Warning System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.
The primary objective of the research is to determine the ability of the Brain Sentinel Seizure Detection System to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).The primary endpoint will be the sensitivity of GTC seizure detection (defined as within 30 seconds of motor manifestation via vEEG analysis) in a hospital setting.
Measured: less than 1 month
Secondary outcomes (1)
Comparison of study device to self reporting of seizures using a seizure diary.
The secondary objective is to assess the operation of the Brain Sentinel Seizure Detection System when used in the subject's home and to compare the GTC seizure reporting of the device to a standard seizure diary completed by the subject/caregiver.
Measured: Less than 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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
- 239 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 SentinelDennis Dlugos, MD, Principal investigator, Children's Hospital of PhiladelphiaJonathan Halford, MD, Principal investigator, Medical University of South CarolinaDileep Nair, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874600
- Sponsor's protocol ID
- BS-0421
- Status last verified
- Jul 2019
- First submitted
- 5 Jun 2013
- Last updated
- 10 Jul 2019
- 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 2019. 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 in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT01874600
- Acronym / sponsor ID
- BS-0421
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Jun 2013 (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.
The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy Patients | – | Device: Brain Sentinel Seizure Detection Device 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
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescent epilepsy patients with a history of generalized tonic-clonic seizures either primary GTC or partial onset seizures with second generalization.
Key inclusion criteria (8 listed)
- Subject has a suspected 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 13-21.
- If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
- 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.
Key exclusion criteria (3 listed)
- 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 is allergic to adhesives or any component of the electrode patch assembly
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 Device and Warning SystemThe Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring | Device | Epilepsy Patients |
Primary outcome
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.
Time frame: less than 1 month
The primary objective of the research is to determine the ability of the Brain Sentinel Seizure Detection System to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).The primary endpoint will be the sensitivity of GTC seizure detection (defined as within 30 seconds of motor manifestation via vEEG analysis) in a hospital setting.
1 secondary outcome
Comparison of study device to self reporting of seizures using a seizure diary.
Time frame: Less than 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- 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
Dennis Dlugos, MD principal investigator
Children's Hospital of Philadelphia
Jonathan Halford, MD principal investigator
Medical University of South Carolina
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, 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 3 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. 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?
Results are not available in the source record.
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?
Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG. (time frame: less than 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 2019.