EEG@HOME (Phase 3b of the Project, Interviews) | NCT02428348

Studies
EEG@HOME (Phase 3b of the Project, Interviews)

NCT02428348

Sponsor

University Hospital, Ghent

Status

Terminated

Last Update Posted

Nov 28, 2017Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

Interview about prototype EEG-cap

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Project funding ended before Phase 3b could be completed.

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Apr 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Mar 31, 2015

First Submission Date that Met QC Criteria

Apr 22, 2015

First Posted Date

Apr 28, 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

Name	Class
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.

Phase 3 of this Project will be divided into Phase 3a and Phase 3b.

In Phase 3b of the project epilepsy patients and their family will be interviewed about different EEG-cap models in development. This interview is anticipated to take approximately 1 hour.

Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.

The results of the interviews will be analysed by the design company pilipili nv.

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

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interview	Experimental	Interview of epilepsy patients and their family about their opinion on different EEG-cap models in development.	Other: Interview about prototype EEG-cap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview about prototype EEG-cap	Other		Interview

Measure	Description	Time Frame
User opinion (questionnaire)		1 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Epilepsy patient

Exclusion Criteria:

No experience with EEG

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 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

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