A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary
July 8, 2021 updated by: Scheherazade Le, Stanford University
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford Hospital and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.
Description
Inclusion Criteria:
-Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.
Exclusion Criteria:
- Patients with only non-convulsive events or only psychogenic non-epileptic seizures.
- Patients who are unable to provide consent.
- Patients who have developmental delay.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)
Time Frame: up to 7 days
|
up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG
Time Frame: up to 7 days
|
up to 7 days
|
|
|
Frequency of movements of the watch diary interface vs vEEG
Time Frame: up to 7 days
|
up to 7 days
|
|
|
Amplitude of movements of the watch diary interface vs vEEG
Time Frame: up to 7 days
|
up to 7 days
|
|
|
Seizure semiology captured by the watch vs vEEG.
Time Frame: up to 7 days.
|
up to 7 days.
|
|
|
Specificity of audio recordings of the watch vs vEEG
Time Frame: up to 7 days
|
Will record audio through the watch and vEEG to assess the specificity of this parameter for epileptic vs nonepileptic seizures
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up to 7 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recording accuracy of convulsive seizure events by the watch and watch-diary interface compared to vEEG
Time Frame: up to 7 days
|
Will measure the date and time, duration and shake intensity of convulsive seizure events by the watch and watch-diary interface compared to vEEG
|
up to 7 days
|
|
Feasibility of use of device
Time Frame: up to 7 days
|
Will survey whether the device was easy, neutral, difficult to use
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up to 7 days
|
|
Recording accuracy of partial seizures
Time Frame: up to 7 days
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Will compare partial seizure events detected by vEEG vs. watch-diary vs. patient log vs. caregiver log
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up to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scheherazade Le, MD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 26, 2014
First Submitted That Met QC Criteria
June 26, 2014
First Posted (Estimate)
June 30, 2014
Study Record Updates
Last Update Posted (Actual)
July 14, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM-29027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.