SeizureNCT01436695
Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
An observational study of Seizure, run by Epicall LTD at 1 site in Israel.
Trial summary
Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Seizure
- What is being tested?
- Epicall
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Jun 2012
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Hospitalized patients who diagnosed with epilepsy and meet all of the eligibility criteria will be recruited for the study.
Who may be able to join
- Children age 1 year -18 years old.
- Hospitalized patient who is diagnosed with epilepsy.
- Patient's parents/care giver able to comprehend and give informed consent for participation in this study.
- Patient's parents/care giver must commit to both screening and monitoring visits.
- Patient's parents/care giver must sign the Informed Consent Form.
Who cannot join
- Patient with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in monitoring electrode area
- General weakness.
- Patient's parents/care giver objects to the study protocol.
- Concurrent participation in any other clinical study.
- Physician objection.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Asaf Harofeh Medical Center
Zrifin
Hanna Levy, Dr, +972-4638-8837, hanna@qsitemed.com
Eli Heyman, Dr
About this study
Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease.
The Epicall system is intended for early detection of seizure related life threatening events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG (photoplethysmograph electrode) sensors for continuous monitoring of:
- Heart Rate (base line, increase, decrease, asystole).
- Extra ocular eye movement (blinking, eye deviation, roving eye movements).
- Conditions
- Seizure
- Being tested
- Epicall
- Keywords
- seizure early detection
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpicallDevice
The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Epicall group | patients will be connected to Epicall sensor Receives: Device: Epicall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of adverse events
Measured: 1-2 weeks
Secondary outcomes (1)
Epicall feasibility for monitoring pre-seizure biomarkers
Feasibility of using the Epicall for monitoring pre-seizure biomarkers will be established by the correlation between Epicall and ECG heart rate measurements.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizureStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epicall LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eli Heyman, Dr, Principal investigator, Asaf-Harofeh Medical Center, Zrifin Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436695
- Sponsor's protocol ID
- EPC - 01
- Status last verified
- Sep 2011
- First submitted
- 17 Sep 2011
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers
- ClinicalTrials.gov ID
- NCT01436695
- Acronym / sponsor ID
- EPC - 01
- Conditions
- Seizure
- Keywords
- seizure early detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Epicall LTDIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (estimated)
- First posted
- 20 Sep 2011 (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.
Epilepsy is a syndrome of episodic brain dysfunction characterized by recurrent seemingly unpredictable spontaneous seizures. The occurrence of the seizure in patients without any forewarning is the most debilitating aspect of the disease.
The Epicall system is intended for early detection of seizure related life threatening events by monitoring per-seizures biomarkers. The system is based on a sticker placed on the side of the face. The external sticker incorporates EOG (electrooculograph electrode) and PPG (photoplethysmograph electrode) sensors for continuous monitoring of:
- Heart Rate (base line, increase, decrease, asystole).
- Extra ocular eye movement (blinking, eye deviation, roving eye movements).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epicall group | – | Device: Epicallpatients will be connected to Epicall sensor |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hospitalized patients who diagnosed with epilepsy and meet all of the eligibility criteria will be recruited for the study.
Key inclusion criteria (5 listed)
- Children age 1 year -18 years old.
- Hospitalized patient who is diagnosed with epilepsy.
- Patient's parents/care giver able to comprehend and give informed consent for participation in this study.
- Patient's parents/care giver must commit to both screening and monitoring visits.
- Patient's parents/care giver must sign the Informed Consent Form.
Key exclusion criteria (5 listed)
- Patient with any infection / abscess / bleeding / blister / crack / edema / fissure / ulcer / pain in monitoring electrode area
- General weakness.
- Patient's parents/care giver objects to the study protocol.
- Concurrent participation in any other clinical study.
- Physician objection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpicallThe Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers. | Device | Epicall group |
Primary outcome
Lack of adverse events
Time frame: 1-2 weeks
1 secondary outcome
Epicall feasibility for monitoring pre-seizure biomarkers
Time frame: 1-2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
Related trials for Seizure
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
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.
Eli Heyman, Dr principal investigator
Asaf-Harofeh Medical Center, Zrifin Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizure, run by Epicall LTD at 1 site in Israel.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Levy, Dr (+972-4-638-8837, hanna@qsitemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of adverse events (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
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 20 Sep 2011.