- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03753230
Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions (QUAdEMCE)
November 23, 2018 updated by: Centre Hospitalier Universitaire de Besancon
The study aim to determine the reliability of various EEG wireless headsets.
Their signal will be compared to standard high-density EEG recording during music listening.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Right handed healthy people
- sensitive to "music chill" (Barcelona Reward music Questionnaire>50)
- having given their participation agreement
- individual with health insurance coverage.
Exclusion Criteria:
- Pregnant women
- individuals in "exclusion period" of another study
- subjects with auditory deficits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EEG Device 1
Participants are listening to music while their neural activity is recorded with Emotiv Epoc+
|
Cerebral measurements from electroencephalography devices while music is presented to the participant
|
|
Experimental: EEG Device 2
Participants are listening to music while their neural activity is recorded with g.tec
|
Cerebral measurements from electroencephalography devices while music is presented to the participant
|
|
Active Comparator: High density EEG
Participants are listening to music while their neural activity is recorded with high density 256 electrodes EEG Geodesic
|
Cerebral measurements from electroencephalography devices while music is presented to the participant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality and spatial/temporal coherence in oscillatory responses patterns recorded with EEG wireless headsets (Emotiv and g.tec) and with the EEG high density gold standard
Time Frame: Up to 2 weeks
|
Brain activity will be recorded continuously during musical extract listening.
The coherence of EEG activity between the three different devices on similar electrodes will be measured and compared for several brainwaves (delta, theta, alpha, beta, gamma)
|
Up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2018
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
November 20, 2018
First Submitted That Met QC Criteria
November 23, 2018
First Posted (Actual)
November 26, 2018
Study Record Updates
Last Update Posted (Actual)
November 26, 2018
Last Update Submitted That Met QC Criteria
November 23, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- API/2018/92
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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