Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home

Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication.

In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.

Study Overview

• Status: Terminated
• Conditions: Epilepsy
• Intervention / Treatment: Device: Neuroelectrics Enobio 8(R)

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult epilepsy patients who are admitted to the video EEG unit and are expected to experience seizures during hospitalization

Description

Inclusion Criteria:

• Age >18
• Known diagnosis of Epilepsy
• Expected to experience seizures during the period of the study as determined by the PI.
• Able to meet with the Sponsor representative at home

Exclusion Criteria:

• Trauma/broken skin on forehead.
• Patient can not follow or comply with instructions
• Patients who are unable to independently provide an informed consent
• Patients with major psychiatric co-morbidities
• Patients with psychogenic non-epileptic seizures

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful data collection during hospitalization	Continuous recording from wearable sensors of physiologic signals during hospitalization in the video EEG unit	12 hours daily for up to 5 days
Successful data collection during at home monitoring	Continuous recording from wearable sensors of physiologic signals during at home monitoring	12 hours daily for up to 14 days

Collaborators and Investigators

• Sponsor: Medial Research Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 29, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: CA-EPIPRO-TASMC-HOSP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No