Study of Algorithm for Epilepsy Alert Device
This study has been completed.
Sponsor:
Biolert
Information provided by:
Biolert
ClinicalTrials.gov Identifier:
NCT00497835
First received: July 6, 2007
Last updated: June 14, 2011
Last verified: July 2007
| Tracking Information | |||||
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| First Received Date ICMJE | July 6, 2007 | ||||
| Last Updated Date | June 14, 2011 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00497835 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Algorithm for Epilepsy Alert Device | ||||
| Official Title ICMJE | Epilepsy Alert Device - Epilert Performance | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Biospecimen | no Biospecimen |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients admitted to Video-LTM Unit with motor seizures. |
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| Condition ICMJE | Motor Seizures | ||||
| Intervention ICMJE | |||||
| Study Group/Cohort (s) | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00497835 | ||||
| Other Study ID Numbers ICMJE | Biolert LTD | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Prof. Uri Kramer. Chief scientist, Biolert LTD | ||||
| Study Sponsor ICMJE | Biolert | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Biolert | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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