An observational study in Epilepsy, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Stanford University · Observational
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 30 is below the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.
-Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.
Exclusion Criteria:
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)
Time frame: up to 7 days
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
Will record audio through the watch and vEEG to assess the specificity of this parameter for epileptic vs nonepileptic seizures
Time frame: up to 7 days
Recording accuracy of convulsive seizure events by the watch and watch-diary interface compared to vEEG
Will measure the date and time, duration and shake intensity of convulsive seizure events by the watch and watch-diary interface compared to vEEG
Time frame: up to 7 days
Feasibility of use of device
Will survey whether the device was easy, neutral, difficult to use
Time frame: up to 7 days
Recording accuracy of partial seizures
Will compare partial seizure events detected by vEEG vs. watch-diary vs. patient log vs. caregiver log
Time frame: up to 7 days
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Stanford University