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

Epicall LTD30 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Seizure

Interventions

EpicallDEVICE

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

Eligibility

Medical Language ↔ Plain English

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

Feasibility of using the Epicall for monitoring pre-seizure biomarkers will be established by the correlation between Epicall and ECG heart rate measurements.