Clinical Trial

Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder

Recruiting
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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 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.
Protocol Amendment History 507 amendments
This ClinicalTrials.gov record has been amended 507 times since 2017-10-10; most recent amendment 2026-07-02.
Status change: Suspended → Recruiting 2025-06-13
Status change: Recruiting → Suspended 2024-03-27
Trial Details
NCT Number NCT03307317
Lead Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Developmental Delay
Enrollment 200 participants
Start Date 2018-08-30
Primary Completion 2030-02-01 (estimated)
Study Completion 2031-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13