NCT03753230

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Status
unknown

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

First Submitted

Initial submission to the registry

November 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

November 20, 2018

Last Update Submit

November 23, 2018

Conditions

Musical Emotions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

Study Arms (3)

EEG Device 1

EXPERIMENTAL

Participants are listening to music while their neural activity is recorded with Emotiv Epoc+

Device: Electroencephalography

EEG Device 2

EXPERIMENTAL

Participants are listening to music while their neural activity is recorded with g.tec

Device: Electroencephalography

High density EEG

ACTIVE COMPARATOR

Participants are listening to music while their neural activity is recorded with high density 256 electrodes EEG Geodesic

Device: Electroencephalography

Interventions

ElectroencephalographyDEVICE

Cerebral measurements from electroencephalography devices while music is presented to the participant

EEG Device 1EEG Device 2High density EEG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right handed healthy people
  • sensitive to "music chill" (Barcelona Reward music Questionnaire\>50)
  • having given their participation agreement
  • individual with health insurance coverage.

You may not qualify if:

  • Pregnant women
  • subjects with auditory deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

Lionel PAZART, MD, PhD, MPH

CONTACT

+33 381 218 622lpazart@chu-besancon.fr

Damien GABRIEL, PhD

CONTACT

+33 381 219 148dgabriel@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 26, 2018

Study Start

December 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

November 26, 2018

Record last verified: 2018-11