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EEG@HOME (Phase 4 of the Project)

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ClinicalTrials.gov Identifier: NCT02394639
Recruitment Status : Withdrawn (Project funding ended before reaching Phase 4.)
First Posted : March 20, 2015
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Pilipili NV
Imec
Information provided by (Responsible Party):
Neurologie, University Hospital, Ghent

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.


Condition or disease Intervention/treatment Phase
Epilepsy Other: video-EEG monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Study Start Date : April 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: conventional video-EEG monitoring
conventional video-EEG monitoring with cup-electrodes and collodion
Other: video-EEG monitoring
Experimental: video-EEG monitoring with prototype
video-EEG monitoring of 5 hours with EEG-cap with dry electrodes
Other: video-EEG monitoring



Primary Outcome Measures :
  1. EEG signal quality (visual and clinical) (scale) [ Time Frame: 5 hours ]
  2. EEG signal quality (technical) (signal to noise ratio) [ Time Frame: 5 hours ]
  3. User experience (questionnaire) [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  1. EEG-technologist experience (questionnaire) [ Time Frame: 5 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epilepsy with on EEG prominent IEDs

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394639


Locations
Belgium
University Hospital, Ghent
Ghent, Belgium, 9000
University Hospital, Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Ghent
Universitaire Ziekenhuizen Leuven
Pilipili NV
Imec

Responsible Party: Neurologie, Prof. dr. Kristl Vonck, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02394639     History of Changes
Other Study ID Numbers: EC/2015/0140
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017