NCT02428348

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

March 31, 2015

Last Update Submit

November 27, 2017

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • User opinion (questionnaire)

    1 hour

Study Arms (1)

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

Interview about prototype EEG-capOTHER
Interview

Eligibility Criteria

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

You may qualify if:

  • Epilepsy patient

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

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

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 28, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

November 28, 2017

Record last verified: 2017-11

Locations

BE(1)