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

Epicall

Status: Unknown

Conditions: Seizure

Treatments: Device: Epicall

Study type: Observational

Funder types: Industry

Identifiers

NCT01436695

EPC - 01

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Epicall group

Description:

patients will be connected to Epicall sensor

Treatment:

Device: Epicall