Perception of Baby's Painful Cry in fMRI

NCT ID: NCT03190486

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2018-07-05

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.

Conditions

Magnetic Resonance Imaging; Neuronal Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Men contact-less with children

functional Magnetic Resonance Imaging (fMRI).

Group Type: EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

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

Women contact-less with children

functional Magnetic Resonance Imaging (fMRI).

Group Type: EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

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

Father contact-less with children

functional Magnetic Resonance Imaging (fMRI).

Group Type: EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

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

Mother contact-less with children

functional Magnetic Resonance Imaging (fMRI).

Group Type: EXPERIMENTAL

functional Magnetic Resonance Imaging (fMRI)

Intervention Type: OTHER

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

Interventions

functional Magnetic Resonance Imaging (fMRI)

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

Intervention Type: OTHER

Other Intervention Names

fMRI

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• any contraindications to pass an fMRI test
• Pregnant woman

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital of Saint-Etienne

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland PEYRON, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Service de Neurologie - CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

1708071

Identifier Type: -

Identifier Source: org_study_id