Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
2 other identifiers
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2017
CompletedFirst Posted
Study publicly available on registry
October 11, 2017
CompletedStudy Start
First participant enrolled
August 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2031
January 26, 2026
January 22, 2026
11.4 years
October 7, 2017
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Developmental level
Diagnostic status and behavioral scales that reflect child development at different levels: gross motor, fine motor, language and visual reception.
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.
Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants
Study Arms (3)
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)
Eligibility Criteria
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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
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.
PMID: 25910852BACKGROUNDVanderwert 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.
PMID: 23063953BACKGROUNDAnderson 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.
PMID: 28611578BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir H Gandjbakhche, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2017
First Posted
October 11, 2017
Study Start
August 30, 2018
Primary Completion (Estimated)
February 1, 2030
Study Completion (Estimated)
February 1, 2031
Last Updated
January 26, 2026
Record last verified: 2026-01-22