NCT03753620

Brief Summary

The study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions. The second aim is to validate the correspondence between cerebral areas activated in fMRI and cortical areas identified with high density EEG during the listening of emotional musical pieces.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2.7 years

First QC Date

November 20, 2018

Last Update Submit

June 20, 2022

Conditions

Music Listening

Outcome Measures

Primary Outcomes (1)

  • Correlation between synchronous cerebral hemodynamics and electric patterns recorded with both EEG and fMRI simultaneously during the production of musical emotions.

    The cerebral activity will be measured continuously during musical extracts listening and comparison of the participant self report emotional level will allow to compare fMRI and EEG data to ensure a good correspondence.

    Day 0

Study Arms (1)

Music listening

EXPERIMENTAL

The participants listens to their favorite emotional musical extracts. While listening, their Hemodynamic activity (with fMRI), their cerebral electric activity (with EEG) and their peripheral physiological parameters are recorded simultaneously

Device: simultaneous fMRI and EEG + peripheral measuresDevice: EEG and peripheral measures

Interventions

simultaneous fMRI and EEG + peripheral measuresDEVICE

Hemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening.

Music listening
EEG and peripheral measuresDEVICE

cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.

Music listening

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

Study Sites (1)

CHU de Besançon

Besançon, 25030, France

Location

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 27, 2018

Study Start

May 15, 2019

Primary Completion

January 27, 2022

Study Completion

March 1, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Locations

FR(1)