EpilepsyNCT02329028
Feasibility of Mini-EEG in the Prehospital Setting
An observational study of Epilepsy and Coma, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Prehospital mini-EEG
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2015to Sep 2016
- How long will I take part?
- 4 Weeks
- 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: Unconscious patients in the prehospital field
Who may be able to join
- Unconsciousness resulting in activation of the local EMS units
Who cannot join
- Cardiac arrest
- Traumatic unconsciousness
- Transient unconsciousness
Trial locations and contacts
1 site in 1 country.
About this study
The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Standard EEG devices are large and their operation require meticulous application of several leads. The department of clinical neurophysiology at Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency department as well as in the prehospital setting. The aims of this pilot study is to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes are used. The sample size is 30. Data are collected as a part of the clinical work in daily practice. The aim is to collect observational data on feasibility, no clinical interventions will be performed based on the EEG. No funding is needed as data is collected during daily work.
The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central Hospital, and as such, does not have a trade name. It is to be connected to a monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by Physio-Control, Redmond, WA 98052. (www.physio-control.com)
- Being tested
- Prehospital mini-EEG
- Keywords
- Emergency Care, Prehospital, Electroencephalography, Coma
- Medical subject headings
- Epilepsy, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehospital mini-EEGDevice
Observational
| Study group | Role | What they receive |
|---|---|---|
| Prehospital mini-EEG | Feasibility of prehospital EEG device in unconscious patients. Receives: Device: Prehospital mini-EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal interpretability
evaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)
Measured: 60 min
Device ease-of-use
evaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2016
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
- 23 participants (actual)
- Target duration
- 4 Weeks
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, Ph.D, Study director, Helsinki University Central HospitalTapani Salmi, MD, Ph.D., Study director, Helsinki University Central HospitalJohannes Björkman, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329028
- Sponsor's protocol ID
- 150/13/03/02/2013
- Status last verified
- Sep 2016
- First submitted
- 8 Aug 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Mini-EEG in the Prehospital Setting
- ClinicalTrials.gov ID
- NCT02329028
- Acronym / sponsor ID
- 150/13/03/02/2013
- Keywords
- Emergency Care, Prehospital, Electroencephalography, Coma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (actual)
- First posted
- 31 Dec 2014 (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.
The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Standard EEG devices are large and their operation require meticulous application of several leads. The department of clinical neurophysiology at Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency department as well as in the prehospital setting. The aims of this pilot study is to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes are used. The sample size is 30. Data are collected as a part of the clinical work in daily practice. The aim is to collect observational data on feasibility, no clinical interventions will be performed based on the EEG. No funding is needed as data is collected during daily work.
The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central Hospital, and as such, does not have a trade name. It is to be connected to a monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by Physio-Control, Redmond, WA 98052. (www.physio-control.com)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehospital mini-EEG | – | Device: Prehospital mini-EEGFeasibility of prehospital EEG device in unconscious patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unconscious patients in the prehospital field
Key inclusion criteria (1 listed)
- Unconsciousness resulting in activation of the local EMS units
Key exclusion criteria (3 listed)
- Cardiac arrest
- Traumatic unconsciousness
- Transient 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 |
|---|---|---|
| Prehospital mini-EEGObservational | Device | Prehospital mini-EEG |
Primary outcome
Signal interpretability
Time frame: 60 min
evaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)
Device ease-of-use
Time frame: 60 min
evaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)
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 8 Sep 2016.
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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, Ph.D study director
Helsinki University Central Hospital
Tapani Salmi, MD, Ph.D. study director
Helsinki University Central Hospital
Johannes Björkman, MD principal investigator
Helsinki University Central Hospital
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 Epilepsy and Coma, run by Helsinki University Central Hospital at 1 site in Finland.
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 3 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 8 Sep 2016. 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 Finland. 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?
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.
What does the primary outcome measure?
Signal interpretability (time frame: 60 min). The study lists 2 primary outcomes in all. 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 Sep 2016.