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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

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).

Detailed Summary:
Sponsor: Epicall LTD

Current Primary Outcome: Lack of adverse events [ Time Frame: 1-2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Epicall LTD

Dates:
Date Received: September 17, 2011
Date Started: November 2011
Date Completion:
Last Updated: September 19, 2011
Last Verified: September 2011