search
Back to results

EEG@HOME (Phase 1 of the Project)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Interview
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy

Eligibility Criteria

6 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Epilepsy patient or EEG-technologist or neurologist

Exclusion Criteria:

  • No experience with EEG

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interview

Arm Description

Interview of epilepsy patients and their family about their experience with epilepsy, EEG registrations and daily life. Interview of EEG-technologists and neurologists about their experience with EEG registrations and expections when thinking of a ideal EEG-cap.

Outcomes

Primary Outcome Measures

User wishes and expectations (questionnaire)

Secondary Outcome Measures

Full Information

First Posted
March 31, 2015
Last Updated
December 7, 2015
Sponsor
University Hospital, Ghent
Collaborators
Pilipili NV, Imec
search

1. Study Identification

Unique Protocol Identification Number
NCT02408666
Brief Title
EEG@HOME (Phase 1 of the Project)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Ghent
Collaborators
Pilipili NV, Imec

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, EEG registrations, daily life, ... . In addition EEG-technologists and neurologists will be interviewed about their experience with EEG registrations and what features their dream EEG-cap would have. The purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour. Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50 EEG-technologists or neurologists will be interviewed. The results of the interviews will be analysed by the design company pilipili nv.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interview
Arm Type
Other
Arm Description
Interview of epilepsy patients and their family about their experience with epilepsy, EEG registrations and daily life. Interview of EEG-technologists and neurologists about their experience with EEG registrations and expections when thinking of a ideal EEG-cap.
Intervention Type
Other
Intervention Name(s)
Interview
Primary Outcome Measure Information:
Title
User wishes and expectations (questionnaire)
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Epilepsy patient or EEG-technologist or neurologist Exclusion Criteria: No experience with EEG
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

EEG@HOME (Phase 1 of the Project)

We'll reach out to this number within 24 hrs