Clinical trial NCT02177877: A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary
Official title: A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Seizures
Wrist accelerometer
Epilepsy diary
Seizure detection
Biosensor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: SmartMonitor
First posted: 2014-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)
timeFrame: up to 7 days
Secondary outcomes:
measure: Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG
timeFrame: up to 7 days
measure: Frequency of movements of the watch diary interface vs vEEG
timeFrame: up to 7 days
measure: Amplitude of movements of the watch diary interface vs vEEG
timeFrame: up to 7 days
measure: Seizure semiology captured by the watch vs vEEG.
timeFrame: up to 7 days.
measure: Specificity of audio recordings of the watch vs vEEG
timeFrame: up to 7 days
Other outcomes:
measure: Recording accuracy of convulsive seizure events by the watch and watch-diary interface compared to vEEG
timeFrame: up to 7 days
measure: Feasibility of use of device
timeFrame: up to 7 days
measure: Recording accuracy of partial seizures
timeFrame: up to 7 days
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Scheherazade Le, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.