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

This study is not yet open for participant recruitment.
Verified September 2011 by Epicall LTD
Sponsor:
Information provided by (Responsible Party):
Epicall LTD
ClinicalTrials.gov Identifier:
NCT01436695
First received: September 17, 2011
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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).

Condition Intervention
Seizure
 Device: Epicall

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers

Resource links provided by NLM:

MedlinePlus related topics: Seizures
U.S. FDA Resources

Further study details as provided by Epicall LTD:

Primary Outcome Measures:
  • Lack of adverse events [ Time Frame: 1-2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Epicall feasibility for monitoring pre-seizure biomarkers [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
    Feasibility of using the Epicall for monitoring pre-seizure biomarkers will be established by the correlation between Epicall and ECG heart rate measurements.


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Epicall group
patients will be connected to Epicall sensor
 Device: Epicall
The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized patients who diagnosed with epilepsy and meet all of the eligibility criteria will be recruited for the study.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436695

Contacts
Contact: Hanna Levy, Dr +972-4-638-8837 hanna@qsitemed.com

Locations
Israel
Asaf Harofeh Medical Center Not yet recruiting
Zrifin, Israel
Contact: Hanna Levy, Dr     +972-4638-8837     hanna@qsitemed.com    
Principal Investigator: Eli Heyman, Dr            
Sponsors and Collaborators
Epicall LTD
Investigators
Principal Investigator: Eli Heyman, Dr Asaf-Harofeh Medical Center, Zrifin Israel
  More Information

No publications provided

Responsible Party: Epicall LTD
ClinicalTrials.gov Identifier: NCT01436695     History of Changes
Other Study ID Numbers: EPC - 01
Study First Received: September 17, 2011
Last Updated: September 19, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Epicall LTD:
seizure early detection

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013