Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
1 other identifier
observational
30
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2011
CompletedFirst Posted
Study publicly available on registry
September 20, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedSeptember 20, 2011
September 1, 2011
7 months
September 17, 2011
September 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lack of adverse events
1-2 weeks
Secondary Outcomes (1)
Epicall feasibility for monitoring pre-seizure biomarkers
1-2 weeks
Study Arms (1)
Epicall group
patients will be connected to Epicall sensor
Interventions
The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.
Eligibility Criteria
Hospitalized patients who diagnosed with epilepsy and meet all of the eligibility criteria will be recruited for the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epicall LTDlead
Study Sites (1)
Asaf Harofeh Medical Center
Zrifin, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eli Heyman, Dr
Asaf-Harofeh Medical Center, Zrifin Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2011
First Posted
September 20, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Last Updated
September 20, 2011
Record last verified: 2011-09