Recruiting

Brain Development

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT03307317

Conditions

Developmental Delay

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Developmental Delay

Study ID

NCT03307317

Start date

Aug 30, 2018

Status verified date

Aug 11, 2026

Completion date

Feb 1, 2031

Anticipated

Primary completion date

Feb 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • Developmental level [ Time Frame: Visit 2 for AR group ]
  • Hemodynamic response function and mu suppression [ Time Frame: Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Sep 8, 2026

Last verified

Aug 11, 2026

Keywords

  • Near Infrared Spectroscopy
  • EEG
  • Functional Brain Activity
  • Neurodevelopment
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2026-09-08.