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

Seizure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01436695
• Other study ID #: EPC - 01
• Status: Not yet recruiting
• Phase: N/A
• First received: September 17, 2011
• Last updated: September 19, 2011
• Start date: November 2011

Study information

• Verified date: September 2011
• Source: Epicall LTD
• Contact: Hanna Levy, Dr
• Phone: +972-4-638-8837
• Email: hanna[@]qsitemed.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Seizure
• Seizures

Intervention

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

Locations

Country	Name	City	State
Israel	Asaf Harofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Epicall LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lack of adverse events		1-2 weeks	Yes
Secondary	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.	1-2 weeks	No