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

NCT ID: NCT02177877

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SmartMonitor

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Scheherazade Le

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scheherazade Le, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27205871 (View on PubMed)

Other Identifiers

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SM-29027

Identifier Type: -

Identifier Source: org_study_id

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