Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
Recruitment status was: Not yet recruiting
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:
- Heart Rate (base line, increase, decrease, asystole).
- Extra ocular eye movement (blinking, eye deviation, roving eye movements).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers|
- Lack of adverse events [ Time Frame: 1-2 weeks ] [ Designated as safety issue: Yes ]
- 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.
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
patients will be connected to Epicall sensor
The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436695
|Asaf Harofeh Medical Center|
|Principal Investigator:||Eli Heyman, Dr||Asaf-Harofeh Medical Center, Zrifin Israel|