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

Terminated

• Conditions: Epilepsy

• Registration Number: NCT03038191
• Lead Sponsor: Medial Research Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-29
• Study First Posted: 2017-01-31
• Study Start: 2017-03-08
• Primary Completion: 2018-12-30
• Study Completion: 2019-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-05
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel