Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age9-65
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age of 18-65 at study entry

Healthy and good condition as determined by medical history and physical examination

9 months +/- 2 weeks of age at time of consent

Healthy and good condition as determined by medical history and physical examination

Disqualifiers

Uncorrected auditory impairment

Uncorrected visual impairment

Head injury with loss of consciousness

Inability to provide consent

Trial population

Adult pilots and TD infants will be recruited from a community sample. AR infants will be recruited from local early intervention providers and pediatricians, following procedures of ongoing collaborative studies at NIH.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 3 trial groups
Group A: Adult pilots
Group B: AR infants
Group C: TD infants

Trial outcomes

Primary outcomes

1

Developmental level

Diagnostic status and behavioral scales that reflect child development at different levels: gross motor, fine motor, language and visual reception.

Time frame
Visit 2 for AR group
2

Hemodynamic response function and mu suppression

The change in neuroimaging metrics (i.e., percent mu suppression, percent oxyhemoglobin change) will be used to characterize the development of the mirror neuron system.

Time frame
Visit 1 for Adult Pilot, TD and AR infants; visit 2 for TD infants

Secondary outcomes

Other outcomes

Sponsors and contacts

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