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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03038191
• Other study ID #: CA-EPIPRO-TASMC-HOSP-02
• Status: Terminated
• Start date: March 8, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2021
• Source: Medial Research Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Neuroelectrics Enobio 8(R)
Monitoring

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Medial Research Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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