Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity (NEUREXPLO)

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.

Study Overview

• Status: Completed
• Conditions: Music Listening
• Intervention / Treatment: Device: simultaneous fMRI and EEG + peripheral measures; Device: EEG and peripheral measures

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHU de Besancon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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
• No inclusion criteria of fMRI acquisition
• Subjects with auditory deficits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music listening; 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 measures; Hemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening.; Device: EEG and peripheral measures; cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: API/2017/91

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No