Magnetic Resonance ImagingNCT03190486
Perception of Baby's Painful Cry in fMRI
A study testing functional Magnetic Resonance Imaging (fMRI) in people with Magnetic Resonance Imaging and Neuronal Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Crying is the primary signaling strategy available to the human newborn for eliciting parental care. Yet, the investigators only have superficial understanding of the information carried by cries, and how this information is perceived by parents. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Neuronal Activity
- What is being tested?
- functional Magnetic Resonance Imaging (fMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2017to 5 Jul 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman aged between 18 and 50
- Contact-less with children
- right-handed
- Giving their written informed consent
- Subject who agreed to communicate MRI results to their attending physician
- French Social Security affiliation
Who cannot join
- any contraindications to pass an fMRI test
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perception of Baby's Painful Cry: Investigation in fMRI to Neuronal Activity Related to Empathy in Adults
Crying is the primary signaling strategy available to the human newborn for eliciting parental care. Yet, the investigators only have superficial understanding of the information carried by cries, and how this information is perceived by parents. Using modern tools of sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims to investigate cry-induced brain activation in adult depending on the cry's acoustic properties expressing various degrees of stress and distress levels. For that, Adults will be tested inside a fMRI magnet to determine their brain activations elicited by different babies cries according to whether the cry was evoked in a pain situation or not. The cerebral activity will be investigated in relation to acoustic features of cries (e.g. with pitch and/or roughness variations). To test if the gender or parentally of adult listeners influence their perceptions and brain responses, the task will be applied to 2 different groups (men and women not-parents). The hypothesis is that the brain of adult listeners will be able to discriminate adequately the intensity of the pain mediated by the cries. This process should involve brain areas such as the insular and the orbito frontal cortex that are known to participate in the integration of pain intensity and pain controls. The experiment should also determine which one of the acoustic features is able to transmit pain and to recruit brain areas involved in pain processes.
- Conditions
- Magnetic Resonance Imaging, Neuronal Activity
- Being tested
- functional Magnetic Resonance Imaging (fMRI)
- Keywords
- Baby cries, pain, brain responses, neuroimaging, fMRI
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional Magnetic Resonance Imaging (fMRI)Other
Also called fMRI
During fMRI, healthy volunteers will listen 80 baby's cry.
| Study group | Role | What they receive |
|---|---|---|
| Men contact-less with children | Experimental | functional Magnetic Resonance Imaging (fMRI). Receives: Other: functional Magnetic Resonance Imaging (fMRI) |
| Women contact-less with children | Experimental | functional Magnetic Resonance Imaging (fMRI). Receives: Other: functional Magnetic Resonance Imaging (fMRI) |
| Father contact-less with children | Experimental | functional Magnetic Resonance Imaging (fMRI). Receives: Other: functional Magnetic Resonance Imaging (fMRI) |
| Mother contact-less with children | Experimental | functional Magnetic Resonance Imaging (fMRI). Receives: Other: functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD (blood-oxygen-level dependent) -contrast imaging
Measure of blood-oxygen-level dependent with fMRI during listening to natural crying.
Measured: at inclusion
Secondary outcomes (2)
BOLD (blood-oxygen-level dependent) -contrast imaging
Measure of blood-oxygen-level dependent with by fMRI during listening to artificial crying.
Measured: at inclusion
impact of gender and parenting on perception of baby's cry
Measure of blood-oxygen-level dependent with by fMRI during listening to artificial crying.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start24 Jul 2017
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 20 men and 20 women : group "non parent" 20 father and 20 mother : group "parent"
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Saint-Etienne
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190486
- Sponsor's protocol ID
- 1708071
- Other IDs
- ID-RCB
- Status last verified
- Sep 2018
- First submitted
- 15 Jun 2017
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fauchon C, Corvin S, Faillenot I, Patural H, Reby D, Peyron R, Mathevon N. Parenting and empathy capabilities drive brain response to pain cues in baby cries. Pain. 2026 May 1;167(5):1225-1236. doi: 10.1097/j.pain.0000000000003914. Epub 2026 Jan 15.
PubMed 41557145
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Baby's Painful Cry: Investigation in fMRI to Neuronal Activity Related to Empathy in Adults
- ClinicalTrials.gov ID
- NCT03190486
- Acronym / sponsor ID
- 1708071
- Conditions
- Magnetic Resonance Imaging, Neuronal Activity
- Keywords
- Baby cries, pain, brain responses, neuroimaging, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- University Hospital of Saint-Etienne
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 16 Jun 2017 (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.
Crying is the primary signaling strategy available to the human newborn for eliciting parental care. Yet, the investigators only have superficial understanding of the information carried by cries, and how this information is perceived by parents. Using modern tools of sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims to investigate cry-induced brain activation in adult depending on the cry's acoustic properties expressing various degrees of stress and distress levels. For that, Adults will be tested inside a fMRI magnet to determine their brain activations elicited by different babies cries according to whether the cry was evoked in a pain situation or not. The cerebral activity will be investigated in relation to acoustic features of cries (e.g. with pitch and/or roughness variations). To test if the gender or parentally of adult listeners influence their perceptions and brain responses, the task will be applied to 2 different groups (men and women not-parents). The hypothesis is that the brain of adult listeners will be able to discriminate adequately the intensity of the pain mediated by the cries. This process should involve brain areas such as the insular and the orbito frontal cortex that are known to participate in the integration of pain intensity and pain controls. The experiment should also determine which one of the acoustic features is able to transmit pain and to recruit brain areas involved in pain processes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 20 men and 20 women : group "non parent" 20 father and 20 mother : group "parent"
| Arm | Type | Receives |
|---|---|---|
| Men contact-less with children | Experimental | Other: functional Magnetic Resonance Imaging (fMRI)functional Magnetic Resonance Imaging (fMRI). |
| Women contact-less with children | Experimental | Other: functional Magnetic Resonance Imaging (fMRI)functional Magnetic Resonance Imaging (fMRI). |
| Father contact-less with children | Experimental | Other: functional Magnetic Resonance Imaging (fMRI)functional Magnetic Resonance Imaging (fMRI). |
| Mother contact-less with children | Experimental | Other: functional Magnetic Resonance Imaging (fMRI)functional Magnetic Resonance Imaging (fMRI). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Man or woman aged between 18 and 50
- Contact-less with children
- right-handed
- Giving their written informed consent
- Subject who agreed to communicate MRI results to their attending physician
Key exclusion criteria (2 listed)
- any contraindications to pass an fMRI test
- Pregnant woman
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 |
|---|---|---|
| functional Magnetic Resonance Imaging (fMRI)Also: fMRIDuring fMRI, healthy volunteers will listen 80 baby's cry. | Other | Father contact-less with children, Men contact-less with children, Mother contact-less with children, Women contact-less with children |
Primary outcome
BOLD (blood-oxygen-level dependent) -contrast imaging
Time frame: at inclusion
Measure of blood-oxygen-level dependent with fMRI during listening to natural crying.
2 secondary outcomes
BOLD (blood-oxygen-level dependent) -contrast imaging
Time frame: at inclusion
impact of gender and parenting on perception of baby's cry
Time frame: at inclusion
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 10 Oct 2018.
- Derived from this study: PubMed 41557145Fauchon C, Corvin S, Faillenot I, Patural H, Reby D, Peyron R, Mathevon N. Parenting and empathy capabilities drive brain response to pain cues in baby cries. Pain. 2026 May 1;167(5):1225-1236. doi: 10.1097/j.pain.0000000000003914. Epub 2026 Jan 15.
- Individual participant dataSharing planned: No
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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.
Roland PEYRON, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional Magnetic Resonance Imaging (fMRI) in people with Magnetic Resonance Imaging and Neuronal Activity, run by Centre Hospitalier Universitaire de Saint Etienne 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 6 inclusion and 2 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 10 Oct 2018. 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?
BOLD (blood-oxygen-level dependent) -contrast imaging (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03190486, which also lists 1 linked publication.
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 10 Oct 2018.