What this study is
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.
Study details
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Developmental Delay
- Enrolling
- 200 people
- Starts
- 2018-08-30
- Est. completion
- 2031-02-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 9 Months – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY8664111010prpl@cc.nih.gov
Recruiting
Study team
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study ID 180001
Principal investigator
Amir H Gandjbakhche, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.