A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 26, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 14, 2021
July 1, 2021
1.5 years
June 26, 2014
July 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)
up to 7 days
Secondary Outcomes (5)
Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG
up to 7 days
Frequency of movements of the watch diary interface vs vEEG
up to 7 days
Amplitude of movements of the watch diary interface vs vEEG
up to 7 days
Seizure semiology captured by the watch vs vEEG.
up to 7 days.
Specificity of audio recordings of the watch vs vEEG
up to 7 days
Other Outcomes (3)
Recording accuracy of convulsive seizure events by the watch and watch-diary interface compared to vEEG
up to 7 days
Feasibility of use of device
up to 7 days
Recording accuracy of partial seizures
up to 7 days
Eligibility Criteria
Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.
You may qualify if:
- Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.
You may not qualify if:
- Patients with only non-convulsive events or only psychogenic non-epileptic seizures.
- Patients who are unable to provide consent.
- Patients who have developmental delay.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- SmartMonitorcollaborator
Study Sites (1)
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Related Publications (1)
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.
PMID: 27205871RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scheherazade Le, MD
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
June 26, 2014
First Posted
June 30, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 14, 2021
Record last verified: 2021-07