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

Completed

• Conditions: Epilepsy

• Registration Number: NCT02177877
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-Adults over the age of 18 with known epileptic convulsive seizures already being admitted to the EMU for continuous video EEG.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Will record audio through the watch and vEEG to assess the specificity of this parameter for epileptic vs nonepileptic seizures

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States