- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03190486
Perception of Baby's Painful Cry in fMRI
October 9, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Etienne, France, 42055
- Service de Neurologie - CHU de Saint-Etienne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Men contact-less with children
functional Magnetic Resonance Imaging (fMRI).
|
During fMRI, healthy volunteers will listen 80 baby's cry.
Other Names:
|
|
Experimental: Women contact-less with children
functional Magnetic Resonance Imaging (fMRI).
|
During fMRI, healthy volunteers will listen 80 baby's cry.
Other Names:
|
|
Experimental: Father contact-less with children
functional Magnetic Resonance Imaging (fMRI).
|
During fMRI, healthy volunteers will listen 80 baby's cry.
Other Names:
|
|
Experimental: Mother contact-less with children
functional Magnetic Resonance Imaging (fMRI).
|
During fMRI, healthy volunteers will listen 80 baby's cry.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BOLD (blood-oxygen-level dependent) -contrast imaging
Time Frame: at inclusion
|
Measure of blood-oxygen-level dependent with fMRI during listening to natural crying.
|
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BOLD (blood-oxygen-level dependent) -contrast imaging
Time Frame: at inclusion
|
Measure of blood-oxygen-level dependent with by fMRI during listening to artificial crying.
|
at inclusion
|
|
impact of gender and parenting on perception of baby's cry
Time Frame: at inclusion
|
Measure of blood-oxygen-level dependent with by fMRI during listening to artificial crying.
|
at inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2017
Primary Completion (Actual)
July 5, 2018
Study Completion (Actual)
July 5, 2018
Study Registration Dates
First Submitted
June 15, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 16, 2017
Study Record Updates
Last Update Posted (Actual)
October 10, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1708071
- ID-RCB (Other Identifier: 2026-A00289-42)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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