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EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02408627
Enrollment
3
Registered
2015-04-03
Start date
2015-01-31
Completion date
2015-10-31
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

DEVICEEEG

Sponsors

Pilipili NV
CollaboratorINDUSTRY
Imec
CollaboratorINDUSTRY
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
EEG signal quality (visual and clinical) (scale)10 minutes
EEG signal quality (technical) (signal to noise ratio)10 minutes
User experience (questionnaire)10 minutes

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026