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

September 19, 2011 updated by: Epicall LTD

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zrifin, Israel
        • Asaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lack of adverse events
Time Frame: 1-2 weeks
1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epicall feasibility for monitoring pre-seizure biomarkers
Time Frame: 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.
1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epicall LTD

Investigators

  • Principal Investigator: Eli Heyman, Dr, Asaf-Harofeh Medical Center, Zrifin Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 17, 2011

First Submitted That Met QC Criteria

September 19, 2011

First Posted (Estimate)

September 20, 2011

Study Record Updates

Last Update Posted (Estimate)

September 20, 2011

Last Update Submitted That Met QC Criteria

September 19, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPC - 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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