EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
1 other identifier
interventional
3
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 31, 2015
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 28, 2017
November 1, 2017
9 months
March 31, 2015
November 27, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
EEG signal quality (visual and clinical) (scale)
10 minutes
EEG signal quality (technical) (signal to noise ratio)
10 minutes
User experience (questionnaire)
10 minutes
Study Arms (3)
conventional EEG-registration type 1
ACTIVE COMPARATORconventional EEG-registration with wet bridge electrodes and conductive gel
conventional EEG-registration type 2
ACTIVE COMPARATORconventional EEG-registration with wet cup electrodes and collodion
EEG-registration with dry electrodes
EXPERIMENTALEEG-registration with dry electrodes
Interventions
Eligibility Criteria
You may qualify if:
- Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG
You may not qualify if:
- Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Pilipili NVcollaborator
- Imeccollaborator
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
March 31, 2015
First Posted
April 3, 2015
Study Start
January 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
November 28, 2017
Record last verified: 2017-11