Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03307317
Status:
SUSPENDED
Last Update Posted:
2024-03-28
First Post:
2017-10-07
Brief Title:
Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Mirror Neuron Network Dysfunction as an Early Biomarker of Neurodevelopmental Disorder
Status:
SUSPENDED
Status Verified Date:
2024-10-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Premature suspension of the research by the institution due to audit findings
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 EEGfNIRS 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 EEGfNIRS
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 EEGfNIRS
Some questionnaires and assessments will be videotaped
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 EEGfNIRS 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 EEGfNIRS
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 EEGfNIRS
Some questionnaires and assessments will be videotaped
Detailed Description:
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 actionobservation 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 ie 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
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 actionobservation 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-CH-0001 | None | None | None |