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OpenTrials
Completed

NCT Number: NCT02408627

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

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.

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Key information

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG

Device

Primary outcomes

  1. EEG signal quality (visual and clinical) (scale)

    Time frame: 10 minutes

  2. EEG signal quality (technical) (signal to noise ratio)

    Time frame: 10 minutes

  3. User experience (questionnaire)

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Imec
  • Pilipili NV

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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