NCT03190486

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
Last Updated

October 10, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

June 15, 2017

Last Update Submit

October 9, 2018

Conditions

Keywords

Baby criespainbrain responsesneuroimagingfMRI

Outcome Measures

Primary Outcomes (1)

  • BOLD (blood-oxygen-level dependent) -contrast imaging

    Measure of blood-oxygen-level dependent with fMRI during listening to natural crying.

    at inclusion

Secondary Outcomes (2)

  • BOLD (blood-oxygen-level dependent) -contrast imaging

    at inclusion

  • impact of gender and parenting on perception of baby's cry

    at inclusion

Study Arms (4)

Men contact-less with children

EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI).

Other: functional Magnetic Resonance Imaging (fMRI)

Women contact-less with children

EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI).

Other: functional Magnetic Resonance Imaging (fMRI)

Father contact-less with children

EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI).

Other: functional Magnetic Resonance Imaging (fMRI)

Mother contact-less with children

EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI).

Other: functional Magnetic Resonance Imaging (fMRI)

Interventions

During fMRI, healthy volunteers will listen 80 baby's cry.

Also known as: fMRI
Father contact-less with childrenMen contact-less with childrenMother contact-less with childrenWomen contact-less with children

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details40 women and 40 men
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • any contraindications to pass an fMRI test
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie - CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • 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 Jan 15. doi: 10.1097/j.pain.0000000000003914. Online ahead of print.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roland PEYRON, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 20 men and 20 women : group "non parent" 20 father and 20 mother : group "parent"
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2017

First Posted

June 16, 2017

Study Start

July 24, 2017

Primary Completion

July 5, 2018

Study Completion

July 5, 2018

Last Updated

October 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations