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

NCT ID: NCT03038191

Last Updated: 2021-09-13

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

TERMINATED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-08

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Neuroelectrics Enobio 8(R)

Monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medial Research Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Firas Fahoum, MD

Director, Epilepsy and EEG Service Neurology Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CA-EPIPRO-TASMC-HOSP-02

Identifier Type: -

Identifier Source: org_study_id

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