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

NCT03038191 | Terminated

• 1 other identifier: CA-EPIPRO-TASMC-HOSP-02
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Neuroelectrics Enobio 8(R) DEVICE

Monitoring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medial Research Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Epilepsy and EEG Service Neurology Division

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 31, 2017
• Study Start: March 8, 2017
• Primary Completion: December 30, 2018
• Study Completion: June 30, 2019
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)