Healthy VolunteersMultiLongDevNCT05167565
Longitudinal Development of Behavior and Its Underlying Neural Correlates in Human Infants
A study testing MRI/DTI, EEG and Eye Tracking in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MRI/DTI, EEG and Eye Tracking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2022to 28 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut des Sciences Cognitives (ISC) Laboratoire CNRS UMR6229
Bron, 69500
About this study
Official title: Prospective Study to Investigate Changes in Both Brain and Behavior and Its Underlying Neural Correlates in Human Infants
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
- Being tested
- MRI/DTI, EEG, Eye Tracking, Ages and Stages Questionnaire (ASQ), Infant Behavior Questionnaire Revised (IBQ-R)
- Keywords
- Beta burst activity, Cognitive and motor development, MRI, EEG, behavioral test, Diffusion tensor imaging (DTI), beta bursts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/DTIOther
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.
EEGOther
EEG will be used to record infant brain activity during reaching and grasping actions to analyze beta activity
Eye TrackingOther
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)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)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)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)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 ScaleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Infants aged around 3 month | Experimental | 80 infants aged around 3 months will be included in this study up to around 12.5 months Receives: Other: MRI/DTI; Other: EEG; Other: Eye Tracking; Other: Ages and Stages Questionnaire (ASQ); Other: Infant Behavior Questionnaire Revised (IBQ-R); Other: Beck Depression Inventory (BDI); Other: The Brief Fear of Negative Evaluation Scale (BFNE); Other: Edinburgh Postnatal Depression Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months following the inclusion
Diffusivity
Integrity of white matter fiber tracts assessed by DTI measures of the mean, radial, and axial diffusivity (mm2/s) along them.
Measured: 9 months following the inclusion
Regional myelination
Regional myelination assessed by T1 / T2 intensity ratios.
Measured: 9 months following the inclusion
Secondary outcomes (7)
Motor beta burst timing
The timing relative to movement onset (ms) of beta bursts in the motor cortex, measured with EEG.
Measured: 9 months following the inclusion
Motor beta burst peak frequency
The peak frequency (Hz) of beta bursts in motor cortex, measured with EEG
Measured: 9 months following the inclusion
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.
Measured: 9 months following the inclusion
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).
Measured: 9 months following the inclusion
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).
Measured: 9 months following the inclusion
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)
Measured: 9 months following the inclusion
Edinburgh Postnatal Depression Scale total score
Total score on the Edinburgh Postnatal Depression Scale questionnaire (0-30, with higher scores indicating more depressive symptoms)
Measured: 9 months following the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start17 Oct 2022
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167565
- Sponsor's protocol ID
- 69HCL21_0921
- Other IDs
- 2021-A02238-33
- Acronym
- MultiLongDev
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Investigate Changes in Both Brain and Behavior and Its Underlying Neural Correlates in Human Infants
- ClinicalTrials.gov ID
- NCT05167565
- Acronym / sponsor ID
- MultiLongDev / 69HCL21_0921
- Conditions
- Healthy Volunteers
- Keywords
- Beta burst activity, Cognitive and motor development, MRI, EEG, behavioral test, Diffusion tensor imaging (DTI), beta bursts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants aged around 3 month | Experimental | Other: MRI/DTI, Other: EEG, Other: Eye Tracking, Other: Ages and Stages Questionnaire (ASQ), Other: Infant Behavior Questionnaire Revised (IBQ-R), Other: Beck Depression Inventory (BDI), Other: The Brief Fear of Negative Evaluation Scale (BFNE), Other: Edinburgh Postnatal Depression Scale80 infants aged around 3 months will be included in this study up to around 12.5 months |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI/DTIHigh 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. | Other | Infants aged around 3 month |
| EEGEEG will be used to record infant brain activity during reaching and grasping actions to analyze beta activity | Other | Infants aged around 3 month |
| Eye TrackingInfants 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. | Other | Infants aged around 3 month |
| 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. | Other | Infants aged around 3 month |
| 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. | Other | Infants aged around 3 month |
| 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. | Other | Infants aged around 3 month |
| 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. | Other | Infants aged around 3 month |
| Edinburgh Postnatal Depression ScaleThe 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. | Other | Infants aged around 3 month |
Primary outcome
Fractional anisotropy
Time frame: 9 months following the inclusion
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.
Diffusivity
Time frame: 9 months following the inclusion
Integrity of white matter fiber tracts assessed by DTI measures of the mean, radial, and axial diffusivity (mm2/s) along them.
Regional myelination
Time frame: 9 months following the inclusion
Regional myelination assessed by T1 / T2 intensity ratios.
7 secondary outcomes
Motor beta burst timing
Time frame: 9 months following the inclusion
Motor beta burst peak frequency
Time frame: 9 months following the inclusion
Infant eye movement attentional bias
Time frame: 9 months following the inclusion
Ages and Stages Questionnaire scores
Time frame: 9 months following the inclusion
Infant Behavioral Questionnaire Revised score
Time frame: 9 months following the inclusion
Brief Fear of Negative Evaluation total score
Time frame: 9 months following the inclusion
Edinburgh Postnatal Depression Scale total score
Time frame: 9 months following the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI/DTI, EEG and Eye Tracking in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy (time frame: 9 months following the inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.