Developmental DelayNCT03307317
Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
An observational study of Developmental Delay, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Background: People show changes in brain activity when they watch other people do actions. This may be part of early social and communication skills. Researchers want to understand the stages of normal development of motor observation and imitation in people and how it relates to social development in infants and… Read more about this study
- Who is it for?
- Ages 9 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 1 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 9 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult pilots and TD infants will be recruited from a community sample. AR infants will be recruited from local early intervention providers and pediatricians, following procedures of ongoing collaborative studies at NIH.
Who may be able to join
- Healthy adults
- Age of 18-65 at study entry
- Healthy and good condition as determined by medical history and physical examination
- Healthy Infants
- 9 months +/- 2 weeks of age at time of consent
- Healthy and good condition as determined by medical history and physical examination
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- Age appropriate development as determined by parent report and exam
- Full term at birth
- Normal weight for gestational age
- At Risk Infants
- 12 months +/- 2 weeks at the time of consent
- Must have at least one of the following: observed developmental delay; sibling of a child with autism; premature birth; small for gestational age
Who cannot join
- Healthy Adults
- Uncorrected auditory impairment
- Uncorrected visual impairment
- Head injury with loss of consciousness
- Inability to provide consent
- Subject has a condition, that in the opinion of the investigator, creates an unacceptable risk for participation
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- Healthy and At-Risk Infants
- A language other than English as the primary language spoken at home
- Having a medical impairment that interferes with study participation such as having a g-tube, shunt or seizure disorder and inability to hold one s head upright
- Having a known visual impairment
- Having a known auditory impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Background:
People show changes in brain activity when they watch other people do actions. This may be part of early social and communication skills. Researchers want to understand the stages of normal development of motor observation and imitation in people and how it relates to social development in infants and toddlers.
Read more
Objective:
To study the nature of brain activity that underlies typical brain functioning in infants, toddlers, and adults.
Eligibility:
Infants ages 8 12 months
Healthy adults ages 18 65
Design:
Adult participants will have one visit. They will:
Answer questions about their family, like its size and ethnicity.
Answer questions about their own behavior and do a simple motor task.
Have EEG/fNIRS. A damp elastic cap with small sensors will be placed on the head. Participants will observe stimuli, either on a video screen or of a live person. The sensors will be connected to a computer. That will record the participant s brain activity while watching pictures on a screen.
Infant participants will have 2 visits.
Their parents will answer questions about their family.
The parents will fill out forms about their child s development. These will be mailed to them before each visit.
Parents will stay with their infant while study staff does an assessment of the child s communication, motor, and thinking skills.
Infants will have EEG/fNIRS.
Infants who are at risk for developmental delays will come back for another visit when they are about 2 years old. This will repeat the infant visits but it will not include EEG/fNIRS.
Some questionnaires and assessments will be videotaped.
Read the detailed description
Objective: This investigation has two main objectives: 1) combine two child-friendly brain imaging techniques and stochastic modeling to determine the neural basis for the development of imitation and mimicry in human infants and 2) use machine learning to identify brain activation patterns that predict impairment in imitation and mimicry in infants at risk for social communication disorders.
Study Population: This study will focus on two groups of infants. The first group includes 60 typically developing infants, who will complete the imitation and neuroimaging paradigm between the ages of 9-12 months (+/- 2 weeks) and again at 12 months of age
(+/- 2 weeks). The second group includes 60 infants at increased risk for social communication disorders, including those with motor delay, language delay, preterm birth, or a sibling with an autism spectrum disorder. These infants will complete the imitation and neuroimaging paradigm at 12 months of age (+/- 1 month) as well as a follow up evaluation of social communication skills and developmental status at 24 months of age (+/- 1 month).
Design: We propose to conduct longitudinal studies of changes in EEG and fNIRS correlates of mirror neuron network activity in typical development and infants at risk for social communication delay. We will measure both EEG mu suppression and hemodynamic change over the motor cortex during an established infant action/observation paradigm. At all study visits, infants will also complete developmental assessments that measure abilities in cognitive, motor, language, and social domains.
Outcome measures: Both neuroimaging measures and developmental status will serve as outcomes for this study. For the typically developing infants, change in the neuroimaging metrics (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to
characterize development of the mirror neuron system, while the relation between neuroimaging variables, their trajectories, and developmental ability will be used to develop hypotheses about the role of the mirror neuron network in development of social communication skills. For the infants at risk for social communication disorders, the main outcome will be developmental status, with neuroimaging metrics used as predictors.
- Conditions
- Developmental Delay
- Keywords
- Near Infrared Spectroscopy, EEG, Functional Brain Activity, Neurodevelopment, Natural History
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult pilots | Healthy adults between the ages of 18-65 years | |
| AR infants | Infants with 12 months of age (+/- 2 weeks) with one of the following: observed developmental delay, sibling of a child with autism, premature birth, small for gestational age. | |
| TD infants | Healthy infants with 9 months of age (+/- 2 weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental level
Diagnostic status and behavioral scales that reflect child development at different levels: gross motor, fine motor, language and visual reception.
Measured: Visit 2 for AR group
Hemodynamic response function and mu suppression
The change in neuroimaging metrics (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to characterize the development of the mirror neuron system.
Measured: Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start30 Aug 2018
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amir H Gandjbakhche, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307317
- Sponsor's protocol ID
- 180001
- Other IDs
- 18-CH-0001
- Status last verified
- 11 Aug 2026
- First submitted
- 7 Oct 2017
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thorpe SG, Cannon EN, Fox NA. Spectral and source structural development of mu and alpha rhythms from infancy through adulthood. Clin Neurophysiol. 2016 Jan;127(1):254-269. doi: 10.1016/j.clinph.2015.03.004. Epub 2015 Mar 20.
PubMed 25910852Vanderwert RE, Fox NA, Ferrari PF. The mirror mechanism and mu rhythm in social development. Neurosci Lett. 2013 Apr 12;540:15-20. doi: 10.1016/j.neulet.2012.10.006. Epub 2012 Oct 11.
PubMed 23063953Anderson AA, Smith E, Chowdhry FA, Thurm A, Condy E, Swineford L, Manwaring SS, Amyot F, Matthews D, Gandjbakhche AH. Prefrontal Hemodynamics in Toddlers at Rest: A Pilot Study of Developmental Variability. Front Neurosci. 2017 May 30;11:300. doi: 10.3389/fnins.2017.00300. eCollection 2017.
PubMed 28611578
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
- ClinicalTrials.gov ID
- NCT03307317
- Acronym / sponsor ID
- 180001
- Conditions
- Developmental Delay
- Keywords
- Near Infrared Spectroscopy, EEG, Functional Brain Activity, Neurodevelopment, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 11 Oct 2017 (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.
Background:
People show changes in brain activity when they watch other people do actions. This may be part of early social and communication skills. Researchers want to understand the stages of normal development of motor observation and imitation in people and how it relates to social development in infants and toddlers.
Objective:
To study the nature of brain activity that underlies typical brain functioning in infants, toddlers, and adults.
Eligibility:
Infants ages 8 12 months
Healthy adults ages 18 65
Design:
Adult participants will have one visit. They will:
Answer questions about their family, like its size and ethnicity.
Answer questions about their own behavior and do a simple motor task.
Have EEG/fNIRS. A damp elastic cap with small sensors will be placed on the head. Participants will observe stimuli, either on a video screen or of a live person. The sensors will be connected to a computer. That will record the participant s brain activity while watching pictures on a screen.
Infant participants will have 2 visits.
Their parents will answer questions about their family.
The parents will fill out forms about their child s development. These will be mailed to them before each visit.
Parents will stay with their infant while study staff does an assessment of the child s communication, motor, and thinking skills.
Infants will have EEG/fNIRS.
Infants who are at risk for developmental delays will come back for another visit when they are about 2 years old. This will repeat the infant visits but it will not include EEG/fNIRS.
Some questionnaires and assessments will be videotaped.
Detailed description
Objective: This investigation has two main objectives: 1) combine two child-friendly brain imaging techniques and stochastic modeling to determine the neural basis for the development of imitation and mimicry in human infants and 2) use machine learning to identify brain activation patterns that predict impairment in imitation and mimicry in infants at risk for social communication disorders.
Study Population: This study will focus on two groups of infants. The first group includes 60 typically developing infants, who will complete the imitation and neuroimaging paradigm between the ages of 9-12 months (+/- 2 weeks) and again at 12 months of age
(+/- 2 weeks). The second group includes 60 infants at increased risk for social communication disorders, including those with motor delay, language delay, preterm birth, or a sibling with an autism spectrum disorder. These infants will complete the imitation and neuroimaging paradigm at 12 months of age (+/- 1 month) as well as a follow up evaluation of social communication skills and developmental status at 24 months of age (+/- 1 month).
Design: We propose to conduct longitudinal studies of changes in EEG and fNIRS correlates of mirror neuron network activity in typical development and infants at risk for social communication delay. We will measure both EEG mu suppression and hemodynamic change over the motor cortex during an established infant action/observation paradigm. At all study visits, infants will also complete developmental assessments that measure abilities in cognitive, motor, language, and social domains.
Outcome measures: Both neuroimaging measures and developmental status will serve as outcomes for this study. For the typically developing infants, change in the neuroimaging metrics (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to
characterize development of the mirror neuron system, while the relation between neuroimaging variables, their trajectories, and developmental ability will be used to develop hypotheses about the role of the mirror neuron network in development of social communication skills. For the infants at risk for social communication disorders, the main outcome will be developmental status, with neuroimaging metrics used as predictors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult pilots | – | –Healthy adults between the ages of 18-65 years |
| AR infants | – | –Infants with 12 months of age (+/- 2 weeks) with one of the following: observed developmental delay, sibling of a child with autism, premature birth, small for gestational age. |
| TD infants | – | –Healthy infants with 9 months of age (+/- 2 weeks) |
Who may qualify
- Ages
- 9 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult pilots and TD infants will be recruited from a community sample. AR infants will be recruited from local early intervention providers and pediatricians, following procedures of ongoing collaborative studies at NIH.
Key inclusion criteria (12 listed)
- Healthy adults
- Age of 18-65 at study entry
- Healthy and good condition as determined by medical history and physical examination
- Healthy Infants
- 9 months +/- 2 weeks of age at time of consent
Key exclusion criteria (11 listed)
- Healthy Adults
- Uncorrected auditory impairment
- Uncorrected visual impairment
- Head injury with loss of consciousness
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Developmental level
Time frame: Visit 2 for AR group
Diagnostic status and behavioral scales that reflect child development at different levels: gross motor, fine motor, language and visual reception.
Hemodynamic response function and mu suppression
Time frame: Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants
The change in neuroimaging metrics (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to characterize the development of the mirror neuron system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 25910852Thorpe SG, Cannon EN, Fox NA. Spectral and source structural development of mu and alpha rhythms from infancy through adulthood. Clin Neurophysiol. 2016 Jan;127(1):254-269. doi: 10.1016/j.clinph.2015.03.004. Epub 2015 Mar 20.
- Background: PubMed 23063953Vanderwert RE, Fox NA, Ferrari PF. The mirror mechanism and mu rhythm in social development. Neurosci Lett. 2013 Apr 12;540:15-20. doi: 10.1016/j.neulet.2012.10.006. Epub 2012 Oct 11.
- Background: PubMed 28611578Anderson AA, Smith E, Chowdhry FA, Thurm A, Condy E, Swineford L, Manwaring SS, Amyot F, Matthews D, Gandjbakhche AH. Prefrontal Hemodynamics in Toddlers at Rest: A Pilot Study of Developmental Variability. Front Neurosci. 2017 May 30;11:300. doi: 10.3389/fnins.2017.00300. eCollection 2017.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Amir H Gandjbakhche, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Delay, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 12 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Sep 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria J Ayoub, Ph.D. ((301) 435-9235, maria.ayoub@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental level (time frame: Visit 2 for AR group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307317, which also lists 3 linked publications.
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 8 Sep 2026.