NCT03307317 Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
| NCT ID | NCT03307317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Condition | Developmental Delay |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-08-30 |
| Primary Completion | 2030-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2018-08-30 with a primary completion date of 2030-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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
Contact & Investigator
Amir H Gandjbakhche, Ph.D.
PRINCIPAL INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Frequently Asked Questions
Who can join the NCT03307317 clinical trial?
This trial is open to participants of all sexes, aged 9 Months or older, up to 65 Years, studying Developmental Delay. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03307317 currently recruiting?
Yes, NCT03307317 is actively recruiting participants. Contact the research team at maria.ayoub@nih.gov for enrollment information.
Where is the NCT03307317 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT03307317 clinical trial?
NCT03307317 is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The principal investigator is Amir H Gandjbakhche, Ph.D. at Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The trial plans to enroll 200 participants.