Early mirror-neuron brain activity as a marker for developmental delay
Official title: Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
Run by National Institutes of Health Clinical Center (CC) · NCT03307317 · Data updated 2026-11-12
This study will test whether EEG and fNIRS brain responses during watching and imitating actions can help identify infants (around 9–12 months) who are at risk for social communication delays.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 9 Months to 65 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | August 30, 2018 |
| Main results expected | February 1, 2030 |
| Study ends | February 1, 2031 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT03307317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are typically developing infants around 9 months old, infants at increased risk for social communication delay at about 12 months (for example preterm, small for gestational age, motor or language delay, or having a sibling with autism), and healthy adults aged 18–65 for comparison.
✕Probably not a fit
Children outside the narrow infant age windows, people with conditions that prevent reliable EEG/fNIRS recording (for example uncorrected sensory impairment or recent head injury), or families unable to attend on-site visits are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will record EEG (mu rhythms) and fNIRS hemodynamic responses while infants, at-risk infants, and adults watch and perform simple actions to map mirror neuron network activity. The design is longitudinal for infants, with typically developing infants tested at about 9 and 12 months and at-risk infants tested at 12 months with developmental follow-up at 24 months, while adults complete a single visit for comparison. Signals will be analyzed using stochastic modeling and machine learning to find activation patterns linked to later social-communication outcomes. The project aims to define normal developmental trajectories of action observation/imitation and detect early deviations associated with later impairment.
Why it matters
Potential benefit: If successful, this could enable earlier identification of infants at risk for social communication disorders so interventions can begin sooner.
How similar studies have gone: Prior EEG and fNIRS work on mirror-system activity in infants has shown promising but mixed findings, and combining both modalities with machine learning for prediction is a relatively novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITIERIA: 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 * 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 EXCLUSION CRITERIA: 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 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
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Amir H Gandjbakhche, Ph.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study coordinator: Maria J Ayoub, Ph.D.
- Email: maria.ayoub@nih.gov
- Phone: (301) 435-9235
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.