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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177877
• Other study ID #: SM-29027
• Status: Completed
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	SmartMonitor

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	up to 7 days
Other	Feasibility of use of device	Will survey whether the device was easy, neutral, difficult to use	up to 7 days
Other	Recording accuracy of partial seizures	Will compare partial seizure events detected by vEEG vs. watch-diary vs. patient log vs. caregiver log	up to 7 days
Primary	Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG)		up to 7 days
Secondary	Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG		up to 7 days
Secondary	Frequency of movements of the watch diary interface vs vEEG		up to 7 days
Secondary	Amplitude of movements of the watch diary interface vs vEEG		up to 7 days
Secondary	Seizure semiology captured by the watch vs vEEG.		up to 7 days.
Secondary	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	up to 7 days