Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers

NCT ID: NCT01436695

Last Updated: 2011-09-20

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Brief Summary

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Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease.

The Epicall system is intended for early detection of seizure related life threatening events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG (photoplethysmograph electrode) sensors for continuous monitoring of:

1. Heart Rate (base line, increase, decrease, asystole).
2. Extra ocular eye movement (blinking, eye deviation, roving eye movements).

Detailed Description

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Conditions

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Seizure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Epicall group

patients will be connected to Epicall sensor

Epicall

Intervention Type DEVICE

The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.

Interventions

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Epicall

The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children age 1 year -18 years old.
* Hospitalized patient who is diagnosed with epilepsy.
* Patient's parents/care giver able to comprehend and give informed consent for participation in this study.
* Patient's parents/care giver must commit to both screening and monitoring visits.
* Patient's parents/care giver must sign the Informed Consent Form.

Exclusion Criteria

* Patient with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in monitoring electrode area
* General weakness.
* Patient's parents/care giver objects to the study protocol.
* Concurrent participation in any other clinical study.
* Physician objection.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epicall LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eli Heyman, Dr

Role: PRINCIPAL_INVESTIGATOR

Asaf-Harofeh Medical Center, Zrifin Israel

Locations

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Asaf Harofeh Medical Center

Zrifin, , Israel

Site Status

Countries

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Israel

Central Contacts

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Hanna Levy, Dr

Role: CONTACT

+972-4-638-8837

Facility Contacts

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Hanna Levy, Dr

Role: primary

+972-4638-8837

Other Identifiers

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EPC - 01

Identifier Type: -

Identifier Source: org_study_id

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