We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Algorithm for Epilepsy Alert Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497835
First Posted: July 9, 2007
Last Update Posted: June 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biolert
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497835


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

Responsible Party: Prof. Uri Kramer. Chief scientist, Biolert LTD
ClinicalTrials.gov Identifier: NCT00497835     History of Changes
Other Study ID Numbers: Biolert LTD
First Submitted: July 6, 2007
First Posted: July 9, 2007
Last Update Posted: June 15, 2011
Last Verified: July 2007

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