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EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02408653
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
Pilipili NV
Imec
Information provided by (Responsible Party):
Neurologie, University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE March 31, 2015
First Posted Date  ICMJE April 3, 2015
Last Update Posted Date November 28, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
  • EEG signal quality (visual and clinical) (scale) [ Time Frame: 10 minutes ]
  • EEG signal quality (technical) (signal to noise ratio) [ Time Frame: 10 minutes ]
  • User experience (questionnaire) [ Time Frame: 10 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)
Official Title  ICMJE Not Provided
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 Phase 2 of the project will comprise of an EEG-registration with the different types of electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations, for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP measurement with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-registration will take between 5 and 10 minutes.

Minimum 2 - maximum 10 healthy volunteers 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Epilepsy
Intervention  ICMJE Device: EEG
Study Arms  ICMJE
  • Active Comparator: conventional EEG-registration type 1
    conventional EEG-registration with wet bridge electrodes and conductive gel
    Intervention: Device: EEG
  • Active Comparator: conventional EEG-registration type 2
    conventional EEG-registration with wet cup electrodes and collodion
    Intervention: Device: EEG
  • Experimental: EEG-registration with dry electrodes
    EEG-registration with dry electrodes
    Intervention: Device: EEG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2015)
4
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02408653
Other Study ID Numbers  ICMJE EC/2014/0319(2)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Neurologie, University Hospital, Ghent
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Ghent
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Pilipili NV
  • Imec
Investigators  ICMJE Not Provided
PRS Account University Hospital, Ghent
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP