EpilepsyNCT02752373
A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
An observational study of Epilepsy, run by Brain Sentinel at 1 site in United States.
Trial summary
This is an open label prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure detection 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
- What is being tested?
- Brain Sentinel Seizure Detection and Information System
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Feb 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: People 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 greater than 2 years of age
- Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 16-51 cm)
- Be able to tolerate wearing the device on the upper arm
- 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
- At least 2 or more Emergency Department visits in the previous 12 months for seizure related care
Who cannot join
- The subject is homeless or in a home without a power supply.
- The subject is allergic to adhesives or any component of the electrode patch assembly.
- The subject self-reports that she is pregnant or planning to become pregnant while using the device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is an open label prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic (GTC) Seizures.
Read the detailed description
The Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System is for recording and storing sEMG data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure Detection and Information System is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. It may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs.
- Conditions
- Epilepsy
- Being tested
- Brain Sentinel Seizure Detection and Information System
- Keywords
- GTC Seizures
- 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 and Information SystemDevice
The Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System is for recording and storing sEMG data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure Detection and Information System is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. It may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in associated healthcare costs for patients with a GTC seizure detection and information system
Evaluate the change in associated healthcare costs for patients 12 months prior as compared to 2 months and each 6 months of system use and compared to a similar population of epilepsy patients.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Secondary outcomes (12)
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change of the number of Emergency Department Visits
The change in number of Emergency Department visits will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of inpatient hospitalizations
The change in number of inpatient hospitalizations will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of EEGs
The change in number of EEGs will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of Long Term Video EEG Monitoring (LTM)
The change in number of Long Term Video EEG Monitoring (LTM) will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of outpatient clinic visits in patients
The change in number of outpatient clinic visits in patients will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of no-shows and/or patient cancellations
The change in number of no-shows and/or patient cancellations will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing the change in seizure frequency for each type (reported as per month)
Change in seizure frequency for each type (reported as per month) will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing change in epilepsy etiology (including, but not limited to a new diagnosis of psychogenic non-epileptic spells)
Change in epilepsy etiology (including, but not limited to a new diagnosis of psychogenic non-epileptic spells) will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing clarification of diagnosis
Clarification of diagnosis, if applicable, will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing change in epilepsy treatment
Change in epilepsy treatment will be compared between the 12 months prior to receiving the device and at 2 months and after 6 months of device use.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
To evaluate the impact of epilepsy on families and patients ages > 11 receiving Brain Sentinel® System
Assess data captured on Impact on Families questionnaire collected at baseline, 2 months, and each 6 month time period during use of the device.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
To evaluate the change in quality of life for patients ages > 11 receiving Brain Sentinel® System
Assess data captured on Quality of Life in Epilepsy questionnaire collected at baseline, 2 months, and each 6 month time period during use of the device.
Measured: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionFeb 2017
Why it stopped: This study was terminated due to low enrollment
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
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Anup Patel, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752373
- Sponsor's protocol ID
- HE-1.5-03.2016
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2016
- Last updated
- 20 Mar 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 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization
- ClinicalTrials.gov ID
- NCT02752373
- Acronym / sponsor ID
- HE-1.5-03.2016
- Conditions
- Epilepsy
- Keywords
- GTC Seizures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated due to low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- May 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 27 Apr 2016 (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 an open label prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic (GTC) Seizures.
Detailed description
The Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System is for recording and storing sEMG data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure Detection and Information System is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. It may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People 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 greater than 2 years of age
- Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 16-51 cm)
- Be able to tolerate wearing the device on the upper arm
- 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)
- The subject is homeless or in a home without a power supply.
- The subject is allergic to adhesives or any component of the electrode patch assembly.
- The subject self-reports that she is pregnant or planning to become pregnant while using the device.
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 Information SystemThe Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System is for recording and storing sEMG data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure Detection and Information System is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. It may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs. | Device | – |
Primary outcome
Evaluate the change in associated healthcare costs for patients with a GTC seizure detection and information system
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate the change in associated healthcare costs for patients 12 months prior as compared to 2 months and each 6 months of system use and compared to a similar population of epilepsy patients.
12 secondary outcomes
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change of the number of Emergency Department Visits
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of inpatient hospitalizations
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of EEGs
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of Long Term Video EEG Monitoring (LTM)
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of outpatient clinic visits in patients
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system in the form of the change in number of no-shows and/or patient cancellations
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing the change in seizure frequency for each type (reported as per month)
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing change in epilepsy etiology (including, but not limited to a new diagnosis of psychogenic non-epileptic spells)
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing clarification of diagnosis
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Evaluate impact on healthcare utilization for patients with a GTC seizure detection and information system by assessing change in epilepsy treatment
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
To evaluate the impact of epilepsy on families and patients ages > 11 receiving Brain Sentinel® System
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
To evaluate the change in quality of life for patients ages > 11 receiving Brain Sentinel® System
Time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use
Results and safety
The study was stopped early (reason given: This study was terminated due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 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.
Anup Patel, MD principal investigator
Nationwide Children's Hospital
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: stopped early, as of the sponsor's last update on 20 Mar 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 was stopped early (reason given: This study was terminated due to low enrollment). 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?
Evaluate the change in associated healthcare costs for patients with a GTC seizure detection and information system (time frame: 12 months prior to receiving the device and at 2 months and after 6 months of device use). 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 20 Mar 2017.