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Study of Algorhithm for Epilepsy Alert Device
This study is not yet open for participant recruitment.
Verified by Biolert, July 2007
First Received: July 6, 2007   No Changes Posted
Sponsored by: Biolert
Information provided by: Biolert
ClinicalTrials.gov Identifier: NCT00497835
  Purpose

An accelerometer with transmitting ability is worn on the wrist. Data of movements during seizures will be analyzed to upgrade algorhithm that will identify seizures.


Condition
Motor Seizures

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title: Epilepsy Alert Device - Epilert Performance

Further study details as provided by Biolert:

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: December 2008
Detailed Description:

Patients undergoing Video-EEG telemetry will wear movement sensor on their wrist. The sensor will transmitt continuous data to a laptop. Seizures' data (tonic or clonic) will be analyzed and transformed into an algorhihm (up-graded existing preliminary algorhithm).

In the second phase the algorhythm will need to identify seizure events within one minute of the onset.

Both specifity ("false positive") and sensitivity ("false negative) will be than calculated.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoin Long Term Monitoring for motor seizures

Exclusion Criteria:

  • Invasive recording
  • Psychogenic seizures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497835

Locations
Israel
Tel Aviv, Sourasky, Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Biolert
Investigators
Principal Investigator: Swetlana Kiperwasser, M.D. Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Study ID Numbers: Biolert LTD
Study First Received: July 6, 2007
Last Updated: July 6, 2007
ClinicalTrials.gov Identifier: NCT00497835     History of Changes
Health Authority: Israel: Ministry of Health

Keywords provided by Biolert:
motor seizures
accelerometer
algorhithm
detection
alert

Study placed in the following topic categories:
Signs and Symptoms
Epilepsy
Seizures
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009