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Completed

NCT Number: NCT02177877

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG

    Time frame: up to 7 days

  2. Frequency of movements of the watch diary interface vs vEEG

    Time frame: up to 7 days

  3. Amplitude of movements of the watch diary interface vs vEEG

    Time frame: up to 7 days

  4. Seizure semiology captured by the watch vs vEEG.

    Time frame: up to 7 days.

  5. Specificity of audio recordings of the watch vs vEEG

    Time frame: up to 7 days

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

Other outcomes

  1. Recording accuracy of convulsive seizure events by the watch and watch-diary interface compared to vEEG

    Time frame: up to 7 days

    Will measure the date and time, duration and shake intensity of convulsive seizure events by the watch and watch-diary interface compared to vEEG

  2. Feasibility of use of device

    Time frame: up to 7 days

    Will survey whether the device was easy, neutral, difficult to use

  3. Recording accuracy of partial seizures

    Time frame: up to 7 days

    Will compare partial seizure events detected by vEEG vs. watch-diary vs. patient log vs. caregiver log

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • SmartMonitor

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2014
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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