EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT02408627
• Collaborator: Pilipili NV (Industry), Imec (Industry)
• Enrollment: 3
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 0.3

Study Details

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.

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

Phase 3a of the project will comprise of an EEG-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-recording will take approximately 10 minutes.

Minimum 2 - maximum 10 epilepsy patients 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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Device: EEG	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: conventional EEG-registration type 1 conventional EEG-registration with wet bridge electrodes and conductive gel	Device: EEG
Active Comparator: conventional EEG-registration type 2 conventional EEG-registration with wet cup electrodes and collodion	Device: EEG
Experimental: EEG-registration with dry electrodes EEG-registration with dry electrodes	Device: EEG

Outcome Measures

Primary Outcome Measures

1. EEG signal quality (visual and clinical) (scale) [10 minutes]

2. EEG signal quality (technical) (signal to noise ratio) [10 minutes]

3. User experience (questionnaire) [10 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG

Exclusion Criteria:

• Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent
• Pilipili NV
• Imec

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neurologie, Prof. dr. Kristl Vonck, University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT02408627
• Other Study ID Numbers: EC/2014/1283
• First Posted: Apr 3, 2015
• Last Update Posted: Nov 28, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Epilepsy

Study Results

No Results Posted as of Nov 28, 2017