EpilepsyNCT02177877
A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary
An observational study of Epilepsy, run by Stanford University at 1 site in United States.
Trial summary
This study will assess whether a movement detecting wristwatch can accurately detect seizures and seizure characteristics and record them into an online epilepsy diary. The patients may manually record a description into the online epilepsy diary of the symptoms they experienced before, during or after the seizure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epilepsy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2015
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.
Who may be able to join
- -Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.
Who cannot join
- Patients with only non-convulsive events or only psychogenic non-epileptic seizures.
- Patients who are unable to provide consent.
- Patients who have developmental delay.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Stanford, California, 94305
About this study
This study will assess whether a movement detecting wristwatch can accurately detect seizures and seizure characteristics and record them into an online epilepsy diary. The patients may manually record a description into the online epilepsy diary of the symptoms they experienced before, during or after the seizure.
Read the detailed description
Typically, health care providers receive inaccurate patient self- reports. This pilot trial will document the feasibility of accurately recording and logging seizures into a cloud-based diary, under circumstances of controlled video-EEG monitoring to serve as a comparison "gold standard." More explicitly, we are testing the efficacy of the wristwatch in capturing movement parameters correlated with seizure activity and whether these parameters can be accurately uploaded into an online epilepsy diary. In the future, biosensor data could be valuable to more precisely obtain seizure data for clinical decision making as well as use in clinical trials.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Seizures, Wrist accelerometer, Epilepsy diary, Seizure detection, Biosensor
- Medical subject headings
- Epilepsy, Seizures
What is being measured
The primary outcome is the main question the study is designed to answer.
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)
Measured: up to 7 days
Secondary outcomes (5)
Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG
Measured: up to 7 days
Frequency of movements of the watch diary interface vs vEEG
Measured: up to 7 days
Amplitude of movements of the watch diary interface vs vEEG
Measured: up to 7 days
Seizure semiology captured by the watch vs vEEG.
Measured: up to 7 days.
Specificity of audio recordings of the watch vs vEEG
Will record audio through the watch and vEEG to assess the specificity of this parameter for epileptic vs nonepileptic seizures
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- SmartMonitor
- Responsible party
- Principal investigator, Scheherazade Le, Stanford University
- Investigators
- Scheherazade Le, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177877
- Sponsor's protocol ID
- SM-29027
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2014
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Velez M, Fisher RS, Bartlett V, Le S. Tracking generalized tonic-clonic seizures with a wrist accelerometer linked to an online database. Seizure. 2016 Jul;39:13-18. doi: 10.1016/j.seizure.2016.04.009. Epub 2016 Apr 29.
PubMed 27205871
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary
- ClinicalTrials.gov ID
- NCT02177877
- Acronym / sponsor ID
- SM-29027
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Seizures, Wrist accelerometer, Epilepsy diary, Seizure detection, Biosensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- SmartMonitor
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jun 2014 (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 study will assess whether a movement detecting wristwatch can accurately detect seizures and seizure characteristics and record them into an online epilepsy diary. The patients may manually record a description into the online epilepsy diary of the symptoms they experienced before, during or after the seizure.
Detailed description
Typically, health care providers receive inaccurate patient self- reports. This pilot trial will document the feasibility of accurately recording and logging seizures into a cloud-based diary, under circumstances of controlled video-EEG monitoring to serve as a comparison "gold standard." More explicitly, we are testing the efficacy of the wristwatch in capturing movement parameters correlated with seizure activity and whether these parameters can be accurately uploaded into an online epilepsy diary. In the future, biosensor data could be valuable to more precisely obtain seizure data for clinical decision making as well as use in clinical trials.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.
Key inclusion criteria (1 listed)
- -Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.
Key exclusion criteria (3 listed)
- Patients with only non-convulsive events or only psychogenic non-epileptic seizures.
- Patients who are unable to provide consent.
- Patients who have developmental delay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)
Time frame: up to 7 days
5 secondary outcomes
Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG
Time frame: up to 7 days
Frequency of movements of the watch diary interface vs vEEG
Time frame: up to 7 days
Amplitude of movements of the watch diary interface vs vEEG
Time frame: up to 7 days
Seizure semiology captured by the watch vs vEEG.
Time frame: up to 7 days.
Specificity of audio recordings of the watch vs vEEG
Time frame: up to 7 days
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 14 Jul 2021.
- Results publication: PubMed 27205871Velez M, Fisher RS, Bartlett V, Le S. Tracking generalized tonic-clonic seizures with a wrist accelerometer linked to an online database. Seizure. 2016 Jul;39:13-18. doi: 10.1016/j.seizure.2016.04.009. Epub 2016 Apr 29.
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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.
Scheherazade Le, MD principal investigator
Stanford University
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 Stanford University 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 1 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: finished, as of the sponsor's last update on 14 Jul 2021. 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?
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG) (time frame: up to 7 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 NCT02177877, which also lists 1 linked publication.
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 14 Jul 2021.