EpilepsyNCT02428348
EEG@HOME (Phase 3b of the Project, Interviews)
A study testing Interview about prototype EEG-cap 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?
- Interview about prototype EEG-cap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 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 patient
Who cannot join
- No experience with 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 this Project will be divided into Phase 3a and Phase 3b.
Read more
In Phase 3b of the project epilepsy patients and their family will be interviewed about different EEG-cap models in development. This interview is anticipated to take approximately 1 hour.
Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.
The results of the interviews will be analysed by the design company pilipili nv.
- Conditions
- Epilepsy
- Being tested
- Interview about prototype EEG-cap
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview about prototype EEG-capOther
| Study group | Role | What they receive |
|---|---|---|
| Interview | Experimental | Interview of epilepsy patients and their family about their opinion on different EEG-cap models in development. Receives: Other: Interview about prototype EEG-cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
User opinion (questionnaire)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionOct 2015
Why it stopped: Project funding ended before Phase 3b could be completed.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT02428348
- Sponsor's protocol ID
- EC/2014/1283(2)
- 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 3b of the Project, Interviews)
- ClinicalTrials.gov ID
- NCT02428348
- Acronym / sponsor ID
- EC/2014/1283(2)
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project funding ended before Phase 3b could be completed.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Pilipili NV, Imec
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 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 this Project will be divided into Phase 3a and Phase 3b.
In Phase 3b of the project epilepsy patients and their family will be interviewed about different EEG-cap models in development. This interview is anticipated to take approximately 1 hour.
Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.
The results of the interviews will be analysed by the design company pilipili nv.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interview | Experimental | Other: Interview about prototype EEG-capInterview of epilepsy patients and their family about their opinion on different EEG-cap models in development. |
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 patient
Key exclusion criteria (1 listed)
- No experience with 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 |
|---|---|---|
| Interview about prototype EEG-cap | Other | Interview |
Primary outcome
User opinion (questionnaire)
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Project funding ended before Phase 3b could be completed.). Results are not available in the source record.
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 Interview about prototype EEG-cap 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: stopped early, 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 was stopped early (reason given: Project funding ended before Phase 3b could be completed.). Results are not available in the source record.
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?
User opinion (questionnaire) (time frame: 1 hour). 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.