Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study ID
NCT03307317
Status
Recruiting
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Conditions

  • Developmental Delay

Eligibility Criteria

Sex
ALL
Age
9 Months - 65 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Aug 30, 2018
Status verified
Jan 2026
Primary completion
Feb 1, 2030
Completion
Feb 1, 2031

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Adult pilots
    Healthy adults between the ages of 18-65 years
  • Arm: 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.
  • Arm: TD infants
    Healthy infants with 9 months of age (+/- 2 weeks)

Primary Outcome Measure

Developmental level [ Time Frame: Visit 2 for AR group ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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