NCT01436695UnknownNot Applicable
Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
Epicall LTD1 site in 1 country30 target enrollmentStarted: November 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Lack of adverse events
Study Overview
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:
- Heart Rate (base line, increase, decrease, asystole).
- Extra ocular eye movement (blinking, eye deviation, roving eye movements).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Lack of adverse events
Time Frame: 1-2 weeks
Secondary Outcomes
- Epicall feasibility for monitoring pre-seizure biomarkers(1-2 weeks)
Investigators
Study Sites (1)
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