Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
NCT ID: NCT01436695
Last Updated: 2011-09-20
Study Results
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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UNKNOWN
30 participants
OBSERVATIONAL
2011-11-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Epicall group
patients will be connected to Epicall sensor
Epicall
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* General weakness.
* Patient's parents/care giver objects to the study protocol.
* Concurrent participation in any other clinical study.
* Physician objection.
1 Year
18 Years
ALL
No
Sponsors
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Epicall LTD
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EPC - 01
Identifier Type: -
Identifier Source: org_study_id
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