NCT02408666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

March 31, 2015

Last Update Submit

December 7, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • User wishes and expectations (questionnaire)

    1 hour

Study Arms (1)

Interview

OTHER

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.

Other: Interview

Interventions

Interview

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Epilepsy patient or EEG-technologist or neurologist

You may not qualify if:

  • No experience with EEG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Kristl Vonck

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations