EpilepsyNCT02408627
EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
A study testing EEG in people with Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Oct 2015
- Phase
- Interventional
- 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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG
Who cannot join
- Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.
Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.
Read more
Phase 3a of the project will comprise of an EEG-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-recording will take approximately 10 minutes.
Minimum 2 - maximum 10 epilepsy patients will be included.
There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.
- Conditions
- Epilepsy
- Being tested
- EEG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
| Study group | Role | What they receive |
|---|---|---|
| conventional EEG-registration type 1 | Active comparator | conventional EEG-registration with wet bridge electrodes and conductive gel Receives: Device: EEG |
| conventional EEG-registration type 2 | Active comparator | conventional EEG-registration with wet cup electrodes and collodion Receives: Device: EEG |
| EEG-registration with dry electrodes | Experimental | EEG-registration with dry electrodes Receives: Device: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG signal quality (visual and clinical) (scale)
Measured: 10 minutes
EEG signal quality (technical) (signal to noise ratio)
Measured: 10 minutes
User experience (questionnaire)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
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 University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Pilipili NV, Imec
- Responsible party
- Principal investigator, Neurologie, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408627
- Sponsor's protocol ID
- EC/2014/1283
- Status last verified
- Nov 2017
- First submitted
- 31 Mar 2015
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
- ClinicalTrials.gov ID
- NCT02408627
- Acronym / sponsor ID
- EC/2014/1283
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Pilipili NV, Imec
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Apr 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.
The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.
Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.
Phase 3a of the project will comprise of an EEG-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-recording will take approximately 10 minutes.
Minimum 2 - maximum 10 epilepsy patients will be included.
There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional EEG-registration type 1 | Active comparator | Device: EEGconventional EEG-registration with wet bridge electrodes and conductive gel |
| conventional EEG-registration type 2 | Active comparator | Device: EEGconventional EEG-registration with wet cup electrodes and collodion |
| EEG-registration with dry electrodes | Experimental | Device: EEGEEG-registration with dry electrodes |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG
Key exclusion criteria (1 listed)
- Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG
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 |
|---|---|---|
| EEG | Device | EEG-registration with dry electrodes, conventional EEG-registration type 1, conventional EEG-registration type 2 |
Primary outcome
EEG signal quality (visual and clinical) (scale)
Time frame: 10 minutes
EEG signal quality (technical) (signal to noise ratio)
Time frame: 10 minutes
User experience (questionnaire)
Time frame: 10 minutes
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 28 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG in people with Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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 28 Nov 2017. 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 Belgium. 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?
EEG signal quality (visual and clinical) (scale) (time frame: 10 minutes). The study lists 3 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 28 Nov 2017.