Protocol Details
Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
This study is currently recruiting participants.
Summary
Number |
18-CH-0001 |
Sponsoring Institute |
National Institute of Child Health and Human Development (NICHD) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 9 Mo
Max Age: 65 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Adults who are or may become unable to consent;
Non-English Speaking |
Keywords |
Near Infrared Spectroscopy;
EEG;
Functional Brain Activity;
Neurodevelopment;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Developmental Delay |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Child Health and Human Development |
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
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
Citations:
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.
Vanderwert 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.
Anderson 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. PMID: 28611578; PMCID: PMC5447733.
Contacts:
Clinical Trials Number:
NCT03307317