EpilepsyNCT02344706
Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus
An observational study of Epilepsy and Status Epilepticus, run by Helsinki University Central Hospital.
Trial summary
A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Status Epilepticus
- What is being tested?
- Registration of EEG
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 1 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients unconscious due to seizures in the prehospital field
Who may be able to join
- Unconsciousness due to seizures in the prehospital field
Who cannot join
- Cardiac arrest
- Traumatic unconsciousness
Trial locations and contacts
No sites are listed yet.
Tom Silfvast, MD, PhD contact
About this study
A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.
- Conditions
- Epilepsy, Status Epilepticus
- Being tested
- Registration of EEG
- Keywords
- Emergency Care, Prehospital, Coma, Electroencephalography
- Medical subject headings
- Epilepsy, Status Epilepticus, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration of EEGDevice
EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.
| Study group | Role | What they receive |
|---|---|---|
| Mini-EEG, NCSE | Unconscious patients due to seizures, of whom EEG is registered Receives: Device: Registration of EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of EEG
EEG signal assessed by a physician educated in interpretation of EEG, use a numeric scale (eg 0=not of value/corrupted, 5=good signal with diagnostic value)
Measured: 60min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start1 Dec 2018 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Björkman, Helsinki University Central Hospital
- Investigators
- Tom Silfvast, MD, Phd, Study director, Helsinki University Central HospitalJohannes Björkman, MD, Principal investigator, Helsinki University Central HospitalSalmi Tapani, MD, PHD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344706
- Sponsor's protocol ID
- 237/3 03.12.2012
- Status last verified
- Aug 2018
- First submitted
- 16 Jan 2015
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus
- ClinicalTrials.gov ID
- NCT02344706
- Acronym / sponsor ID
- 237/3 03.12.2012
- Conditions
- Epilepsy, Status Epilepticus
- Keywords
- Emergency Care, Prehospital, Coma, Electroencephalography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 26 Jan 2015 (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.
A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mini-EEG, NCSE | – | Device: Registration of EEGUnconscious patients due to seizures, of whom EEG is registered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients unconscious due to seizures in the prehospital field
Key inclusion criteria (1 listed)
- Unconsciousness due to seizures in the prehospital field
Key exclusion criteria (2 listed)
- Cardiac arrest
- Traumatic unconsciousness
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 |
|---|---|---|
| Registration of EEGEEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient. | Device | Mini-EEG, NCSE |
Primary outcome
Diagnostic value of EEG
Time frame: 60min
EEG signal assessed by a physician educated in interpretation of EEG, use a numeric scale (eg 0=not of value/corrupted, 5=good signal with diagnostic value)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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.
Tom Silfvast, MD, PhD contact
Tom Silfvast, MD, Phd study director
Helsinki University Central Hospital
Johannes Björkman, MD principal investigator
Helsinki University Central Hospital
Salmi Tapani, MD, PHD study director
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Status Epilepticus, run by Helsinki University Central Hospital.
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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Björkman, MD (094711, johannes.bjorkman@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of EEG (time frame: 60min). 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 8 Aug 2018.