Seizures, MotorNCT04291716
Study to Validate Novel Seizure-Detection Algorithm
A study testing Motor Seizure Detection Algorithm (mSDA) in people with Seizures, Motor and Seizures, run by Overwatch Digital Health at 1 site in United States.
Trial summary
The specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (Motor Seizure Detection Algorithm [mSDA]) installed on a wearable device to be worn by the subject. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures, Motor, Seizures, Seizure Disorder
- What is being tested?
- Motor Seizure Detection Algorithm (mSDA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2020to Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Meets the standard of care criteria for admission to an epilepsy monitoring unit (EMU).
- Male or female.
- Aged 18 and above.
- The patient has experienced at least one generalized major motor seizure prior to admission.
- Agreement to wear a wristwatch throughout the duration of the study on the left wrist.
- Ability to cancel false positive alarms via interaction with the application on the watch.
Who cannot join
- Concurrent physiological diseases with movement disorders (Parkinson's, tremor, ataxia, Huntington's, paralysis of the upper body, pseudo-seizures).
- Known allergic reactions to components of the (watch materials).
- Treatment with another investigational drug or other intervention within the study
- Children under the age of 18.
- Women who are pregnant or nursing.
- Inability to give consent to the study.
- Active skin infection or rash on the upper extremities
Trial locations and contacts
1 site in 1 country.
United States1 site
Covenant Hospital and Covenant Medical Group
Lubbock, Texas, 79410
About this study
Official title: Validation of an Algorithm for Identification and Notification of Generalized Major Motor Seizures
The specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (Motor Seizure Detection Algorithm [mSDA]) installed on a wearable device to be worn by the subject. The software will be tested using subjects from a patient population in an epilepsy monitoring unit (EMU) undergoing video and electroencephalograph (VEEG) observation. The number of generalized major motor seizures detected by the mSDA will be compared with those detected by VEEG.
Read the detailed description
Seizures are paroxysmal, abnormal behaviors which usually are associated with altered awareness and amnesia. The frequency of seizures is not easily documented. The individual who suffers from seizures may be unaware that a seizure is occurring. Many seizures, including generalized major motor seizures, have stereotyped, vigorous motor activity associated with the events.
Currently, accurate seizure detection relies on EEG and video which are limited by time, size and mobility. Seizure detection can also use biomarkers such as movement patterns described by gyroscopes. These devices can monitor patterns of movement which correspond to the activity during seizures and kept in a log of seizures without patient input. The log can be used to notify patients or caregivers of seizures.
This study is to determine the accuracy of a system using a commercial, wearable device linked to a computer algorithm based in the cloud which stores the movement pattern and notifies the patient and others of a generalized major motor seizure. The accuracy will be determined by a comparison of the system detections to simultaneously recorded video electroencephalogram, considered the "gold standard" of seizure detection.
- Conditions
- Seizures, Motor, Seizures, Seizure Disorder, Epilepsy, Epileptic Seizures, Epileptic
- Being tested
- Motor Seizure Detection Algorithm (mSDA)
- Keywords
- Epilepsy, Mobile Health, Seizure, Major motor seizure, Epileptic convulsion, Epilepsy monitoring
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Seizure Detection Algorithm (mSDA)Device
A seizure detection algorithm installed on a propriety mobile application to be used on a commercially available watch with a gyroscope to detect movement.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | This is a single-arm study. All subjects enrolled in the study will wear the device during stay in the EMU. Receives: Device: Motor Seizure Detection Algorithm (mSDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Number of major motor seizure detections by algorithm with detection by video encephalogram data.
Measured: 1 to 5 days
Secondary outcomes (4)
False positive rate
Total number of false positives and number of false positives per day.
Measured: 1 to 5 days
Mean detection latency
Time between algorithm detection and application notification
Measured: 1 to 5 days
Notifications
Total number of seizure notifications received on subject's assigned email
Measured: 1 to 5 days
Cancellations
Total number of cancellations of false positive alerts made by the subject.
Measured: 1 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Seizures, MotorStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single cohort of subjects male or female, aged 18 and above who are epilepsy patients who have been admitted to an epilepsy monitoring unit (EMU).
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overwatch Digital Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bracane Company
- Responsible party
- Sponsor
- Investigators
- Haytham Elgammal, MD, Principal investigator, Overwatch Digital HealthSubha Sarcar, PhD, Study director, Bracane Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291716
- Sponsor's protocol ID
- OW012019
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8.
PubMed 28276060Proposal for revised clinical and electroencephalographic classification of epileptic seizures. From the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1981 Aug;22(4):489-501. doi: 10.1111/j.1528-1157.1981.tb06159.x. No abstract available.
PubMed 6790275Kramer U, Kipervasser S, Shlitner A, Kuzniecky R. A novel portable seizure detection alarm system: preliminary results. J Clin Neurophysiol. 2011 Feb;28(1):36-8. doi: 10.1097/WNP.0b013e3182051320.
PubMed 21221012Janse SA, Dumanis SB, Huwig T, Hyman S, Fureman BE, Bridges JFP. Patient and caregiver preferences for the potential benefits and risks of a seizure forecasting device: A best-worst scaling. Epilepsy Behav. 2019 Jul;96:183-191. doi: 10.1016/j.yebeh.2019.04.018. Epub 2019 May 29.
PubMed 31150998Jalloul N. Wearable sensors for the monitoring of movement disorders. Biomed J. 2018 Aug;41(4):249-253. doi: 10.1016/j.bj.2018.06.003. Epub 2018 Sep 11.
PubMed 30348268Muennig PA, Glied SA. What changes in survival rates tell us about us health care. Health Aff (Millwood). 2010 Nov;29(11):2105-13. doi: 10.1377/hlthaff.2010.0073. Epub 2010 Oct 7.
PubMed 20930036Johansson D, Malmgren K, Alt Murphy M. Wearable sensors for clinical applications in epilepsy, Parkinson's disease, and stroke: a mixed-methods systematic review. J Neurol. 2018 Aug;265(8):1740-1752. doi: 10.1007/s00415-018-8786-y. Epub 2018 Feb 9.
PubMed 29427026Nijsen TM, Arends JB, Griep PA, Cluitmans PJ. The potential value of three-dimensional accelerometry for detection of motor seizures in severe epilepsy. Epilepsy Behav. 2005 Aug;7(1):74-84. doi: 10.1016/j.yebeh.2005.04.011.
PubMed 15975855Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
PubMed 25928634Beniczky S, Polster T, Kjaer TW, Hjalgrim H. Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: a prospective, multicenter study. Epilepsia. 2013 Apr;54(4):e58-61. doi: 10.1111/epi.12120. Epub 2013 Feb 8.
PubMed 23398578
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Algorithm for Identification and Notification of Generalized Major Motor Seizures
- ClinicalTrials.gov ID
- NCT04291716
- Acronym / sponsor ID
- OW012019
- Conditions
- Seizures, Motor, Seizures, Seizure Disorder, Epilepsy, Epileptic Seizures, Epileptic
- Keywords
- Epilepsy, Mobile Health, Seizure, Major motor seizure, Epileptic convulsion, Epilepsy monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Overwatch Digital HealthIndustry (pharma, biotech, devices)
- Collaborators
- Bracane Company
- Study start
- Mar 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Mar 2020 (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.
The specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (Motor Seizure Detection Algorithm [mSDA]) installed on a wearable device to be worn by the subject. The software will be tested using subjects from a patient population in an epilepsy monitoring unit (EMU) undergoing video and electroencephalograph (VEEG) observation. The number of generalized major motor seizures detected by the mSDA will be compared with those detected by VEEG.
Detailed description
Seizures are paroxysmal, abnormal behaviors which usually are associated with altered awareness and amnesia. The frequency of seizures is not easily documented. The individual who suffers from seizures may be unaware that a seizure is occurring. Many seizures, including generalized major motor seizures, have stereotyped, vigorous motor activity associated with the events.
Currently, accurate seizure detection relies on EEG and video which are limited by time, size and mobility. Seizure detection can also use biomarkers such as movement patterns described by gyroscopes. These devices can monitor patterns of movement which correspond to the activity during seizures and kept in a log of seizures without patient input. The log can be used to notify patients or caregivers of seizures.
This study is to determine the accuracy of a system using a commercial, wearable device linked to a computer algorithm based in the cloud which stores the movement pattern and notifies the patient and others of a generalized major motor seizure. The accuracy will be determined by a comparison of the system detections to simultaneously recorded video electroencephalogram, considered the "gold standard" of seizure detection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single cohort of subjects male or female, aged 18 and above who are epilepsy patients who have been admitted to an epilepsy monitoring unit (EMU).
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Motor Seizure Detection Algorithm (mSDA)This is a single-arm study. All subjects enrolled in the study will wear the device during stay in the EMU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Meets the standard of care criteria for admission to an epilepsy monitoring unit (EMU).
- Male or female.
- Aged 18 and above.
Key exclusion criteria (7 listed)
- Concurrent physiological diseases with movement disorders (Parkinson's, tremor, ataxia, Huntington's, paralysis of the upper body, pseudo-seizures).
- Known allergic reactions to components of the (watch materials).
- Treatment with another investigational drug or other intervention within the study
- Children under the age of 18.
- Women who are pregnant or nursing.
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 |
|---|---|---|
| Motor Seizure Detection Algorithm (mSDA)A seizure detection algorithm installed on a propriety mobile application to be used on a commercially available watch with a gyroscope to detect movement. | Device | Single Arm |
Primary outcome
Sensitivity
Time frame: 1 to 5 days
Number of major motor seizure detections by algorithm with detection by video encephalogram data.
4 secondary outcomes
False positive rate
Time frame: 1 to 5 days
Mean detection latency
Time frame: 1 to 5 days
Notifications
Time frame: 1 to 5 days
Cancellations
Time frame: 1 to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Background: PubMed 28276060Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8.
- Background: PubMed 6790275Proposal for revised clinical and electroencephalographic classification of epileptic seizures. From the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1981 Aug;22(4):489-501. doi: 10.1111/j.1528-1157.1981.tb06159.x. No abstract available.
- Background: PubMed 21221012Kramer U, Kipervasser S, Shlitner A, Kuzniecky R. A novel portable seizure detection alarm system: preliminary results. J Clin Neurophysiol. 2011 Feb;28(1):36-8. doi: 10.1097/WNP.0b013e3182051320.
- Background: PubMed 31150998Janse SA, Dumanis SB, Huwig T, Hyman S, Fureman BE, Bridges JFP. Patient and caregiver preferences for the potential benefits and risks of a seizure forecasting device: A best-worst scaling. Epilepsy Behav. 2019 Jul;96:183-191. doi: 10.1016/j.yebeh.2019.04.018. Epub 2019 May 29.
- Background: PubMed 30348268Jalloul N. Wearable sensors for the monitoring of movement disorders. Biomed J. 2018 Aug;41(4):249-253. doi: 10.1016/j.bj.2018.06.003. Epub 2018 Sep 11.
- Background: PubMed 20930036Muennig PA, Glied SA. What changes in survival rates tell us about us health care. Health Aff (Millwood). 2010 Nov;29(11):2105-13. doi: 10.1377/hlthaff.2010.0073. Epub 2010 Oct 7.
- Background: PubMed 29427026Johansson D, Malmgren K, Alt Murphy M. Wearable sensors for clinical applications in epilepsy, Parkinson's disease, and stroke: a mixed-methods systematic review. J Neurol. 2018 Aug;265(8):1740-1752. doi: 10.1007/s00415-018-8786-y. Epub 2018 Feb 9.
- Background: PubMed 15975855Nijsen TM, Arends JB, Griep PA, Cluitmans PJ. The potential value of three-dimensional accelerometry for detection of motor seizures in severe epilepsy. Epilepsy Behav. 2005 Aug;7(1):74-84. doi: 10.1016/j.yebeh.2005.04.011.
- Background: PubMed 25928634Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.
- Background: PubMed 23398578Beniczky S, Polster T, Kjaer TW, Hjalgrim H. Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: a prospective, multicenter study. Epilepsia. 2013 Apr;54(4):e58-61. doi: 10.1111/epi.12120. Epub 2013 Feb 8.
- Sponsor websiteLink provided by the sponsor.
- 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.
Haytham Elgammal, MD principal investigator
Overwatch Digital Health
Subha Sarcar, PhD study director
Bracane Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Seizure Detection Algorithm (mSDA) in people with Seizures, Motor and Seizures, run by Overwatch Digital Health 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 7 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 2 Mar 2020. 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?
Contact Chis Czura, PhD (214-662-7322, chris.czura@overwatchdh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 1 to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291716, which also lists 10 linked publications.
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 2 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.