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A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary

A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02177877
Enrollment
30
Registered
2014-06-30
Start date
2014-06-30
Completion date
2015-12-31
Last updated
2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, Seizures, Wrist accelerometer, Epilepsy diary, Seizure detection, Biosensor

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.

Interventions

None listed

Sponsors

SmartMonitor
CollaboratorUNKNOWN
Stanford University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)up to 7 days

Secondary

MeasureTime frameDescription
Frequency of movements of the watch diary interface vs vEEGup to 7 days
Amplitude of movements of the watch diary interface vs vEEGup to 7 days
Seizure semiology captured by the watch vs vEEG.up to 7 days.
Specificity of audio recordings of the watch vs vEEGup to 7 daysWill record audio through the watch and vEEG to assess the specificity of this parameter for epileptic vs nonepileptic seizures
Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEGup to 7 days

Other

MeasureTime frameDescription
Recording accuracy of partial seizuresup to 7 daysWill compare partial seizure events detected by vEEG vs. watch-diary vs. patient log vs. caregiver log
Feasibility of use of deviceup to 7 daysWill survey whether the device was easy, neutral, difficult to use
Recording accuracy of convulsive seizure events by the watch and watch-diary interface compared to vEEGup to 7 daysWill measure the date and time, duration and shake intensity of convulsive seizure events by the watch and watch-diary interface compared to vEEG

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026