Longitudinal Development of Behavior and Its Underlying Neural Correlates in Human Infants

Healthy Volunteers Clinical Trial

— MultiLongDev  

Official title:

Prospective Study to Investigate Changes in Both Brain and Behavior and Its Underlying Neural Correlates in Human Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167565
• Other study ID #: 69HCL21_0921
• Secondary ID: 2021-A02238-33
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: August 17, 2025

Study information

• Verified date: September 2023
• Source: Hospices Civils de Lyon
• Contact: James BONAIUTO, PhD
• Phone: 06 49 34 87 61
• Email: james.bonaiuto[@]isc.cnrs.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The unique importance of human brain development during the first years of life is unquestionable. During an infant's first year, the brain undergoes its most dramatic structural and functional changes, with factors such as early social experience having a significant effect on this development. This study proposes to investigate changes in both brain and behavior across the first 12 months of life. At three time points (~3, 6, and 12 month), anatomical and diffusion magnetic resonance imaging (MRI), resting state functional magnetic resonance imaging (fMRI), electroencephalography (EEG), eye tracking, and observational data will be obtained from the same sample of infants. These measures will be used to track the development of important sensorimotor, socio-emotional, and cognitive skills and their underlying neural correlates, as well as investigate the effects of early social experience on specific aspects of this development

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 17, 2025
• Est. primary completion date: August 17, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

• Healthy newborns, boys and girls, aged 3 months

• Uncomplicated pregnancy and delivery, APGAR scores >8

• Full-term birth without identified neuromotor problems at birth

• No congenital or developmental anomalies affecting the brain

• No reported history of neurological disorders or learning disabilities in the infants

• No reported specific visual, developmental and cognitive impairment

• Absence of medication having a cerebral or psychological impact

• Both parents/ legal guardian must provide their consent and signature prior to participation of their infant in the study

Exclusion Criteria:

• Severe congenital malformation

• Infants requiring a corrective surgery

• Any refusal of a parent

• Infants with severe impairment of the general condition and vital functions

• Infants with dermatitis of the face or scalp

• Infants who receive neurological treatment

• Infants born pre-term (birth before 37 weeks gestation)

• Infants whose mothers have significant medical conditions and/or had significant complications during pregnancy

• Infants who are adopted,

• Infants who have a first degree relative with autism, intellectual disability, schizophrenia, or bipolar disorder,

• Infants who have any significant medical and/or genetic conditions affecting growth, development, or cognition,

• Infants who have any contraindication to MRI (metallic object, surgical material like cochlear implant)

• Maternal pre- eclampsia, placental abruption, maternal HIV status, and maternal alcohol or illicit drug use during pregnancy.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• MRI/DTI
High resolution MRI scans will be acquired from each infant at three time points (~3, 6, and 12 months), while they are naturally asleep to measure the progressive myelination of the major brain fiber tracks, grey matter maturation, and to create generative models for source reconstruction of EEG sensor data.
• EEG
EEG will be used to record infant brain activity during reaching and grasping actions to analyze beta activity
• Eye Tracking
Infants will be presented with the experimental stimuli, which will consist of images of adults displaying different facial expressions and non-social images (e.g. a cross, a geometric pattern). This procedure is based on commonly used eye tracking paradigms designed to assess attention biases in infancy. Infant eye movement and position will be measured during stimuli presentation.
• Ages and Stages Questionnaire (ASQ)
The parents will be asked to complete the ASQ questionnaire (Developmental questionnaire). ASQ-3 has 5 aspects: Communication, Gross motor, Fine motor, Problem solving and Personal-Social Each aspect has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects.
• Infant Behavior Questionnaire Revised (IBQ-R)
The parents will be asked to complete the IBQ-R questionnaire (Developmental questionnaire). The 191-item instrument provides scores on 14 temperament scales which in turn cluster into 3 overarching factors: Positive Affectivity/Surgency, Negative Emotionality, and Orienting/Regulatory Capacity. Items are rated on a 7-point scale.
• Beck Depression Inventory (BDI)
The parents will be asked to complete the BDI questionnaire (Mental health questionnaire). Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.
• The Brief Fear of Negative Evaluation Scale (BFNE)
The parents will be asked to complete the BFNE questionnaire (Mental health questionnaire). The BFNE measures anxiety associated with perceived negative evaluation. This scale is composed of 12 items describing fearful or worrying cognition. Scores from for each item are added up to obtain the total score.
• Edinburgh Postnatal Depression Scale
The parents will be asked to complete the Edinburgh Postnatal Depression Scale (Mental health questionnaire). This is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. The total score is calculated by adding the numbers selected for each of the 10 items. If the parent's score is 10 points or above, they should speak to a health professional about those symptoms.

Locations

Country	Name	City	State
France	Institut des Sciences Cognitives (ISC) Laboratoire CNRS UMR6229	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional anisotropy	Integrity of white matter fiber tracts assessed by DTI measures of the mean fractional anisotropy (0-1, where 0=isotropic diffusion, 1=diffusion restricted along one dimension) along them.	9 months following the inclusion
Primary	Diffusivity	Integrity of white matter fiber tracts assessed by DTI measures of the mean, radial, and axial diffusivity (mm2/s) along them.	9 months following the inclusion
Primary	Regional myelination	Regional myelination assessed by T1 / T2 intensity ratios.	9 months following the inclusion
Secondary	Motor beta burst timing	The timing relative to movement onset (ms) of beta bursts in the motor cortex, measured with EEG.	9 months following the inclusion
Secondary	Motor beta burst peak frequency	The peak frequency (Hz) of beta bursts in motor cortex, measured with EEG	9 months following the inclusion
Secondary	Infant eye movement attentional bias	The proportion of time spent fixating to threatening (ABT) and positive (ABP) facial expressions relative to neutral, measured using eye-tracking.	9 months following the inclusion
Secondary	Ages and Stages Questionnaire scores	Scores on the gross motor, fine motor, and personal-social aspects of the Ages and Stages Questionnaire (0-60, with higher scores indicating normal development).	9 months following the inclusion
Secondary	Infant Behavioral Questionnaire Revised score	Scores on the approach, vocal reactivity, high intensity pleasure, smiling and laughter, activity level, perceptual sensitivity, sadness, distress to limitations, fear, falling reactivity / rate of recovery from distress, low intensity pleasure, cuddliness, duration and orienting, and soothability scales of the Infant Behavioral Questionnaire Revised (0-7, with high scores indicating higher levels on each temperament trait).	9 months following the inclusion
Secondary	Brief Fear of Negative Evaluation total score	Total score on the Brief Fear of Negative Evaluation questionnaire (0-60, with higher scores indicating higher social anxiety)	9 months following the inclusion
Secondary	Edinburgh Postnatal Depression Scale total score	Total score on the Edinburgh Postnatal Depression Scale questionnaire (0-30, with higher scores indicating more depressive symptoms)	9 months following the inclusion