Perception of Baby's Painful Cry in fMRI


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Verified June 2017 by Centre Hospitalier Universitaire de Saint Etienne

Sponsor:

Collaborator:

University Hospital of Saint-Etienne

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT03190486

First received: June 15, 2017

Last updated: June 15, 2017

Last verified: June 2017

Crying is the primary signaling strategy available to the human newborn for eliciting parental care. Yet, we 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). Our 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.

Magnetic Resonance Imaging
Neuronal Activity
Other: functional Magnetic Resonance Imaging (fMRI)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

20 men and 20 women

Masking: No masking
Primary Purpose: Other

Official Title: Perception of Baby’s Painful Cry: Investigation in fMRI to Neuronal Activity Related to Empathy in Adults

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 40
Anticipated Study Start Date: July 1, 2017
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)
Experimental: Men contact-less with children

functional Magnetic Resonance Imaging (fMRI).

Other: functional Magnetic Resonance Imaging (fMRI)

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

Other Name: fMRI

Experimental: Women contact-less with children

functional Magnetic Resonance Imaging (fMRI).

Other: functional Magnetic Resonance Imaging (fMRI)

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

Other Name: fMRI

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   20 women and 20 men
Accepts Healthy Volunteers:   Yes

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03190486

Service de Neurologie – CHU de Saint-Etienne
Saint-Etienne, France, 42055
Principal Investigator: Roland PEYRON, MD         

Centre Hospitalier Universitaire de Saint Etienne

University Hospital of Saint-Etienne

Principal Investigator: Roland PEYRON, MD CHU SAINT-ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03190486     History of Changes
Other Study ID Numbers: 1708071
ID-RCB ( Other Identifier: 2017-A01180-53 )
Study First Received: June 15, 2017
Last Updated: June 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

Baby cries
pain
brain responses
neuroimaging
fMRI

ClinicalTrials.gov processed this record on June 16, 2017