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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Epicall LTD.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014