Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder



Status:Recruiting
Healthy:No
Age Range:Any - 65
Updated:4/6/2019
Start Date:April 10, 2019
End Date:April 30, 2020
Contact:Helga F De Oliveira Miguel, Ph.D.
Email:helgafilipa.deoliveiramiguel@nih.gov
Phone:(301) 594-0351

Use our guide to learn which trials are right for you!

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 9 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.

Objective: This investigation has two main objectives: 1) combine two child-friendly brain
imaging techniques and stochastic modeling to determine the neural basis for the development
of imitation and mimicry in human infants and 2) use machine learning to identify brain
activation patterns that predict impairment in imitation and mimicry in infants at risk for
social communication disorders.

Study Population: This study will focus on two groups of infants. The first group includes 60
typically developing infants, who will complete the imitation and neuroimaging paradigm
between the ages of 9-12 months (+/- 2 weeks) and again at 12 months of age

(+/- 2 weeks). The second group includes 60 infants at increased risk for social
communication disorders, including those with motor delay, language delay, preterm birth, or
a sibling with an autism spectrum disorder. These infants will complete the imitation and
neuroimaging paradigm at 12 months of age (+/- 1 month) as well as a follow up evaluation of
social communication skills and developmental status at 24 months of age (+/- 1 month).

Design: We propose to conduct longitudinal studies of changes in EEG and fNIRS correlates of
mirror neuron network activity in typical development and infants at risk for social
communication delay. We will measure both EEG mu suppression and hemodynamic change over the
motor cortex during an established infant action/observation paradigm. At all study visits,
infants will also complete developmental assessments that measure abilities in cognitive,
motor, language, and social domains.

Outcome measures: Both neuroimaging measures and developmental status will serve as outcomes
for this study. For the typically developing infants, change in the neuroimaging metrics
(i.e., percent mu suppression, percent oxyhemoglobin change) will be used to

characterize development of the mirror neuron system, while the relation between neuroimaging
variables, their trajectories, and developmental ability will be used to develop hypotheses
about the role of the mirror neuron network in development of social communication skills.
For the infants at risk for social communication disorders, the main outcome will be
developmental status, with neuroimaging metrics used as predictors.

- INCLUSION CRITIERIA:

All participants initial eligibility will be determined via an initial phone screen to
review the eligibility checklist followed by an online survey screen. Inclusion criteria
for the TD infant group includes an age at study entry of 9 months (+/- 2 weeks) and a
history of typical development. Inclusion for the AR infant group includes an age at study
entry of 12 months (+/- 2 weeks) and a history of developmental concerns (e.g., language or
motor delays) and/or presence of a risk factor for developmental delays, including being an
infant sibling of a child with autism or having a history of premature birth. Inclusion
criteria for healthy adult pilots includes age of 18-65 years of age at study entry.

EXCLUSION CRITERIA:

Exclusion criteria for all infants include not having English as a primary language spoken
at home, having a medical impairment that interferes with study participation, and having a
known auditory or visual impairment. Having English as a primary language spoken in the
home is necessary in order to ensure validity of developmental assessments, as they are
given in English. Medical impairments that would interfere with study participation include
inability to hold one s head upright, which would impact an infant s ability to watch
stimuli and wear the EEG/fNIRS cap, or any medical fragility requiring medical frequent
medical assistance (e.g., having a g-tube, shunt, or seizure disorder). Infants must also
have now known visual or auditory impairments based on parent report and medical history,
which is necessary to make sure that all infants are able to see and hear the stimuli
presented.

Additional exclusion criteria for infants in the typically developing group include history
of premature birth, history of being small for gestational age, having a known genetic
disorder, and evidence of current or past developmental delays based on the Mullen Scales
of Early Learning and parent report of developmental history. These exclusion criteria
ensure that the comparison between the typically developing infants and the at-risk infants
is meaningful, and that any lack of findings is not due to unclear group boundaries.

Exclusion criteria for adult pilot participants include having uncorrected auditory or
visual impairment, a head injury with loss of consciousness in the past year, and/or
inability to provide informed consent. We are excluding adults with a recent history of
head injury due to the relation between head injury and functional brain measurements, in
order to ensure that the task and procedure appropriately elicit activation in the mirror
network system.
We found this trial at
2
sites
College Park, Maryland
?
mi
from
College Park, MD
Click here to add this to my saved trials
Bethesda, Maryland 20817
Phone: 301-496-6838
?
mi
from
Bethesda, MD
Click here to add this to my saved trials