EEG@HOME (Phase 4 of the Project) | NCT02394639

Studies
EEG@HOME (Phase 4 of the Project)

NCT02394639

Sponsor

University Hospital, Ghent

Status

Withdrawn

Last Update Posted

Nov 28, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

video-EEG monitoring

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Project funding ended before reaching Phase 4.

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Aug 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Feb 10, 2015

First Submission Date that Met QC Criteria

Mar 16, 2015

First Posted Date

Mar 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2017

Last Update Posted Date

Nov 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Neurologie, Prof. dr. Kristl Vonck, University Hospital, GhentPrincipal Investigator

Lead Sponsor

University Hospital, GhentOTHER

Collaborators

Name	Class
Universitaire Ziekenhuizen KU Leuven	OTHER
Pilipili NV	INDUSTRY
Imec	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional video-EEG monitoring	Active Comparator	conventional video-EEG monitoring with cup-electrodes and collodion	Other: video-EEG monitoring
video-EEG monitoring with prototype	Experimental	video-EEG monitoring of 5 hours with EEG-cap with dry electrodes	Other: video-EEG monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
video-EEG monitoring	Other		conventional video-EEG monitoring video-EEG monitoring with prototype

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EEG signal quality (visual and clinical) (scale)		5 hours
EEG signal quality (technical) (signal to noise ratio)		5 hours
User experience (questionnaire)		5 hours

Secondary Outcomes

Measure	Description	Time Frame
EEG-technologist experience (questionnaire)		5 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Epilepsy with on EEG prominent IEDs

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Ghent		Ghent		9000	Belgium
University Hospital, Leuven

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided