Study Stopped
Project funding ended before reaching Phase 4.
EEG@HOME (Phase 4 of the Project)
1 other identifier
interventional
N/A
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
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Started Apr 2015
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 28, 2017
November 1, 2017
1.3 years
February 10, 2015
November 27, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
EEG signal quality (visual and clinical) (scale)
5 hours
EEG signal quality (technical) (signal to noise ratio)
5 hours
User experience (questionnaire)
5 hours
Secondary Outcomes (1)
EEG-technologist experience (questionnaire)
5 hours
Study Arms (2)
conventional video-EEG monitoring
ACTIVE COMPARATORconventional video-EEG monitoring with cup-electrodes and collodion
video-EEG monitoring with prototype
EXPERIMENTALvideo-EEG monitoring of 5 hours with EEG-cap with dry electrodes
Interventions
Eligibility Criteria
You may qualify if:
- Epilepsy with on EEG prominent IEDs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Universitaire Ziekenhuizen KU Leuvencollaborator
- Pilipili NVcollaborator
- Imeccollaborator
Study Sites (2)
University Hospital, Ghent
Ghent, 9000, Belgium
University Hospital, Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. Kristl Vonck
Study Record Dates
First Submitted
February 10, 2015
First Posted
March 20, 2015
Study Start
April 1, 2015
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
November 28, 2017
Record last verified: 2017-11