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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01436695

Enrollment

Registered

2011-09-20

Start date

2011-11-30

Completion date

Unknown

Last updated

2011-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seizure

Keywords

seizure early detection

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).

Interventions

DEVICEEpicall

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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.

Design outcomes

Primary

Measure	Time frame
Lack of adverse events	1-2 weeks

Secondary

Measure	Time frame	Description
Epicall feasibility for monitoring pre-seizure biomarkers	1-2 weeks	Feasibility of using the Epicall for monitoring pre-seizure biomarkers will be established by the correlation between Epicall and ECG heart rate measurements.

Countries

Israel

Contacts

Primary ContactHanna Levy, Dr

hanna@qsitemed.com+972-4-638-8837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026