EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)

NCT02408653 | Completed DMC

• 1 other identifier: EC/2014/0319(2)
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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 2 of the project will comprise of an EEG-registration with the different types of electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations, for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP measurement with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-registration will take between 5 and 10 minutes. Minimum 2 - maximum 10 healthy volunteers will be included. There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• EEG signal quality (visual and clinical) (scale)

  10 minutes

• EEG signal quality (technical) (signal to noise ratio)

  10 minutes

• User experience (questionnaire)

  10 minutes

Study Arms (3)

conventional EEG-registration type 1

ACTIVE COMPARATOR

conventional EEG-registration with wet bridge electrodes and conductive gel

Device: EEG

conventional EEG-registration type 2

ACTIVE COMPARATOR

conventional EEG-registration with wet cup electrodes and collodion

Device: EEG

EEG-registration with dry electrodes

EXPERIMENTAL

EEG-registration with dry electrodes

Device: EEG

Interventions

EEG DEVICE

EEG-registration with dry electrodes; conventional EEG-registration type 1; conventional EEG-registration type 2

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Pilipili NV: collaborator
• Imec: collaborator

Study Sites (1)

University Hospital, Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• 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: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

BE (1)