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

NCT ID: NCT05167565

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2026-01-28

Brief 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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Infants aged around 3 month

80 infants aged around 3 months will be included in this study up to around 12.5 months

Group Type: EXPERIMENTAL

MRI/DTI

Intervention Type: OTHER

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

Intervention Type: OTHER

EEG will be used to record infant brain activity during reaching and grasping actions to analyze beta activity

Eye Tracking

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

EEG

EEG will be used to record infant brain activity during reaching and grasping actions to analyze beta activity

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut des Sciences Cognitives (ISC) Laboratoire CNRS UMR6229

Bron, , France

Countries

France

Other Identifiers

2021-A02238-33

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL21_0921

Identifier Type: -

Identifier Source: org_study_id