Motor SeizuresNCT00497835
Study of Algorithm for Epilepsy Alert Device
An observational study of Motor Seizures, run by Biolert.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 65 years
- Conditions the study is for
- Motor Seizures
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to Video-LTM Unit with motor seizures.
Who may be able to join
- Patients undergoing Long Term Monitoring for motor seizures
Who cannot join
- Invasive recording
- Psychogenic seizures
About this study
Official title: Epilepsy Alert Device - Epilert Performance
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.
Read the 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.
- Conditions
- Motor Seizures
- Keywords
- motor seizures, accelerometer, algorithm, detection, alert
- Medical subject headings
- Seizures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolert
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Swetlana Kiperwasser, M.D., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497835
- Sponsor's protocol ID
- Biolert LTD
- Status last verified
- Jul 2007
- First submitted
- 6 Jul 2007
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Alert Device - Epilert Performance
- ClinicalTrials.gov ID
- NCT00497835
- Acronym / sponsor ID
- Biolert LTD
- Conditions
- Motor Seizures
- Keywords
- motor seizures, accelerometer, algorithm, detection, alert
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BiolertIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to Video-LTM Unit with motor seizures.
Key inclusion criteria (1 listed)
- Patients undergoing Long Term Monitoring for motor seizures
Key exclusion criteria (2 listed)
- Invasive recording
- Psychogenic seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
Related trials for Motor Seizures
RecruitingPhase 2
Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases
Seizures, Primary Motor Cortex
Not yet recruitingEarly Phase 1
Human Cognition During Surgery: Stimulation-based and Cholinergic Modulation
Epilepsy, Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swetlana Kiperwasser, M.D. principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Seizures, run by Biolert.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2011; AzTrials last refreshed its copy on 28 Oct 2026.