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Understanding Brain Activity in Developmental Delay

This study aims to understand how brain activity changes when people watch others perform actions, which may be linked to early social and communication skills. Researchers want to see how this brain activity develops normally in infants, toddlers, and adults, and how it relates to social development. The study will look at brain activity in healthy adults and infants, as well as infants who may be at higher risk for social communication difficulties, such as those with motor or language delays. The goal is to identify brain patterns that might predict challenges in imitation and social communication in these at-risk infants. There are no specific interventions or drugs being tested in this observational study.

Study design
This is an observational study planning to enroll 200 participants, including healthy adults and infants, and infants at risk for social communication disorders.
What's involved
Adult participants will have one visit, answering questions about their family and behavior, performing a simple motor task, and having EEG/fNIRS (brain activity measurements) taken. Infants will have brain imaging at 9-12 months and again at 12 months, with some also having a follow-up evaluation at 24 months.
Compensation
Not stated in the trial record.
Follow-up
Infants at increased risk for social communication disorders will have a follow-up evaluation of social communication skills and developmental status at 24 months of age.

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NCT03307317

Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder

Recruiting
Not specifiedAges 9–65Observational
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
~200 participants
Updated 2026-08-13 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Developmental level
Measured over Visit 2 for AR group
+1 more outcome measured

Conditions

Developmental Delay

Explore related trials

Developmental DelayNeurodevelopmental Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Amir H Gandjbakhche, Ph.D. · PRINCIPAL_INVESTIGATOR · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who to contact

Maria J Ayoub, Ph.D.
[email protected]
(301) 435-9235
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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
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

What this trial measures

  • Developmental levelVisit 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 suppressionVisit 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.