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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Stanford University
Sponsor:
Collaborator:
SmartMonitor
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02177877
First received: June 26, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.


Condition
Epilepsy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Biosensor for Tracking Seizures: Linking a Wrist Accelerometer to an Online Epilepsy Diary

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Capture rate of convulsive seizure events by the watch and watch-diary interface compared to video electroencephalography (vEEG) [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Capture rate of non-seizure events by the watch and watch-diary interface compared to vEEG [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Frequency of movements of the watch diary interface vs vEEG [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Amplitude of movements of the watch diary interface vs vEEG [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
  • Seizure semiology captured by the watch vs vEEG. [ Time Frame: up to 7 days. ] [ Designated as safety issue: No ]
  • Specificity of audio recordings of the watch vs vEEG [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    Will record audio through the watch and vEEG to assess the specificity of this parameter for epileptic vs nonepileptic seizures


Other Outcome Measures:
  • Recording accuracy of convulsive seizure events by the watch and watch-diary interface compared to vEEG [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    Will measure the date and time, duration and shake intensity of convulsive seizure events by the watch and watch-diary interface compared to vEEG

  • Feasibility of use of device [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    Will survey whether the device was easy, neutral, difficult to use

  • Recording accuracy of partial seizures [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    Will compare partial seizure events detected by vEEG vs. watch-diary vs. patient log vs. caregiver log


Estimated Enrollment: 10
Study Start Date: June 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with epilepsy over the age of 18 enrolled at the Stanford Epilepsy Monitoring Unit.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02177877

Contacts
Contact: Scheherazade Le, MD 6507236469 schele@stanford.edu
Contact: Mariel Velez, MD/PhD 6507239469 mvelez@stanford.edu

Locations
United States, California
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Mariel Velez, MD/PhD    650-723-6469    mvelez@stanford.edu   
Contact: Scheherazade Le, MD    6507236469    schele@stanford.edu   
Principal Investigator: Scheherazade Le, MD         
Sub-Investigator: Mariel Velez, MD/PhD         
Sponsors and Collaborators
Stanford University
SmartMonitor
Investigators
Principal Investigator: Scheherazade Le, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02177877     History of Changes
Other Study ID Numbers: SM-29027
Study First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Epilepsy
Seizures
Wrist accelerometer
Epilepsy diary
Seizure detection
Biosensor

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014