EpilepsyNCT02394639
EEG@HOME (Phase 4 of the Project)
A study testing video-EEG monitoring in people with Epilepsy, run by University Hospital, Ghent at 2 sites 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 4 to 80 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- video-EEG monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- Apr 2015to Sep 2016
- 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 4 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Epilepsy with on EEG prominent IEDs
Who cannot join
- /
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital, Ghent
Ghent, 9000
University Hospital, Leuven
Leuven, 3000
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.
In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU.
Read more
Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype.
There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists will also be collected.
- Conditions
- Epilepsy
- Being tested
- video-EEG monitoring
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-EEG monitoringOther
| Study group | Role | What they receive |
|---|---|---|
| conventional video-EEG monitoring | Active comparator | conventional video-EEG monitoring with cup-electrodes and collodion Receives: Other: video-EEG monitoring |
| video-EEG monitoring with prototype | Experimental | video-EEG monitoring of 5 hours with EEG-cap with dry electrodes Receives: Other: video-EEG monitoring |
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: 5 hours
EEG signal quality (technical) (signal to noise ratio)
Measured: 5 hours
User experience (questionnaire)
Measured: 5 hours
Secondary outcomes (1)
EEG-technologist experience (questionnaire)
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: Project funding ended before reaching Phase 4.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Pilipili NV, Imec
- Responsible party
- Principal investigator, Neurologie, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394639
- Sponsor's protocol ID
- EC/2015/0140
- Status last verified
- Nov 2017
- First submitted
- 10 Feb 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 4 of the Project)
- ClinicalTrials.gov ID
- NCT02394639
- Acronym / sponsor ID
- EC/2015/0140
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project funding ended before reaching Phase 4.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Pilipili NV, Imec
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 20 Mar 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.
In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU.
Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype.
There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists will also be collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional video-EEG monitoring | Active comparator | Other: video-EEG monitoringconventional video-EEG monitoring with cup-electrodes and collodion |
| video-EEG monitoring with prototype | Experimental | Other: video-EEG monitoringvideo-EEG monitoring of 5 hours with EEG-cap with dry electrodes |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Epilepsy with on EEG prominent IEDs
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| video-EEG monitoring | Other | conventional video-EEG monitoring, video-EEG monitoring with prototype |
Primary outcome
EEG signal quality (visual and clinical) (scale)
Time frame: 5 hours
EEG signal quality (technical) (signal to noise ratio)
Time frame: 5 hours
User experience (questionnaire)
Time frame: 5 hours
1 secondary outcome
EEG-technologist experience (questionnaire)
Time frame: 5 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video-EEG monitoring in people with Epilepsy, run by University Hospital, Ghent at 2 sites 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: withdrawn, 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 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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: 5 hours). 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.