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Clinical Trials/NCT02177877
NCT02177877
Completed
Not Applicable

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

Stanford University1 site in 1 country30 target enrollmentJune 2014
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Stanford University
Enrollment
30
Locations
1
Primary Endpoint
Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
December 2015
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scheherazade Le

Principle Investigator

Stanford University

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.

Outcomes

Primary Outcomes

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

Time Frame: up to 7 days

Secondary Outcomes

  • 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)

Study Sites (1)

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