EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- EEG signal quality (technical) (signal to noise ratio)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG
Exclusion Criteria
- •Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG
Arms & Interventions
conventional EEG-registration type 1
conventional EEG-registration with wet bridge electrodes and conductive gel
Intervention: EEG (Device)
conventional EEG-registration type 2
conventional EEG-registration with wet cup electrodes and collodion
Intervention: EEG (Device)
EEG-registration with dry electrodes
EEG-registration with dry electrodes
Intervention: EEG (Device)
Outcomes
Primary Outcomes
EEG signal quality (technical) (signal to noise ratio)
Time Frame: 10 minutes
EEG signal quality (visual and clinical) (scale)
Time Frame: 10 minutes
User experience (questionnaire)
Time Frame: 10 minutes
Secondary Outcomes
No secondary outcomes reported
Investigators
Neurologie
Prof. dr. Kristl Vonck
University Hospital, Ghent