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Study of Algorithm for Epilepsy Alert Device

This study has been completed.
Sponsor:
Information provided by:
Biolert
ClinicalTrials.gov Identifier:
NCT00497835
First received: July 6, 2007
Last updated: June 14, 2011
Last verified: July 2007
History of Changes
  Purpose

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


Condition
Motor Seizures

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epilepsy Alert Device - Epilert Performance

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Biolert:

Biospecimen Description:

no Biospecimen


Enrollment: 15
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

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

Both specificity ("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
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to Video-LTM Unit with motor seizures.

Criteria

Inclusion Criteria:

  • Patients undergoing 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

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

No publications provided

Responsible Party: Prof. Uri Kramer. Chief scientist, Biolert LTD
ClinicalTrials.gov Identifier: NCT00497835     History of Changes
Other Study ID Numbers: Biolert LTD
Study First Received: July 6, 2007
Last Updated: June 14, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Biolert:
motor seizures
accelerometer
algorithm
detection
alert

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

ClinicalTrials.gov processed this record on June 18, 2013