Music ListeningNEUREXPLONCT03753620
Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity
A study testing simultaneous fMRI and EEG + peripheral measures and EEG and peripheral measures in people with Music Listening, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Music Listening
- What is being tested?
- simultaneous fMRI and EEG + peripheral measures and EEG and peripheral measures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right handed healthy people
- Sensitive to "music chill" (Barcelona Reward music Questionnaire>50)
- Having given their participation agreement
- Individual with health insurance coverage.
Who cannot join
- Pregnant women
- Individuals in "exclusion period" of another study
- No inclusion criteria of fMRI acquisition
- Subjects with auditory deficits.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Music Listening
- Being tested
- simultaneous fMRI and EEG + peripheral measures, EEG and peripheral measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
EEG and peripheral measuresDevice
cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: simultaneous fMRI and EEG + peripheral measures; Device: EEG and peripheral measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start15 May 2019
- Primary completion27 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music ListeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753620
- Sponsor's protocol ID
- API/2017/91
- Acronym
- NEUREXPLO
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2018
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity
- ClinicalTrials.gov ID
- NCT03753620
- Acronym / sponsor ID
- NEUREXPLO / API/2017/91
- Conditions
- Music Listening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music listening | Experimental | Device: simultaneous fMRI and EEG + peripheral measures, Device: EEG and peripheral measuresThe 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Right handed healthy people
- Sensitive to "music chill" (Barcelona Reward music Questionnaire>50)
- Having given their participation agreement
- Individual with health insurance coverage.
Key exclusion criteria (4 listed)
- Pregnant women
- Individuals in "exclusion period" of another study
- No inclusion criteria of fMRI acquisition
- Subjects with auditory deficits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simultaneous fMRI and EEG + peripheral measuresHemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening. | Device | Music listening |
| EEG and peripheral measurescerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening. | Device | Music listening |
Primary outcome
Correlation between synchronous cerebral hemodynamics and electric patterns recorded with both EEG and fMRI simultaneously during the production of musical emotions.
Time frame: Day 0
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simultaneous fMRI and EEG + peripheral measures and EEG and peripheral measures in people with Music Listening, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between synchronous cerebral hemodynamics and electric patterns recorded with both EEG and fMRI simultaneously during the production of musical emotions. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.