Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03434080
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2018-02-14
Brief Title:
Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With or at High-risk for Cerebral Palsy and Autism Spectrum Disorder Compared to Infants and Toddlers With Typical Development
Status:
RECRUITING
Status Verified Date:
2024-07-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
New ways to study the brain as people move include near-infrared spectroscopy NIRS and electroencephalography EEG NIRS uses laser light shone through the scalp to look at blood flow in the brain which increases with movement EEG records electrical activity in the brain Little is known about brain activity while children learn new motor skills Researchers want to learn more about how small children with and without cerebral palsy use their brain to control their body This may help them find new ways to help children move better
Objectives
To learn more about how infants and young children with and without cerebral palsy use their brain to move their arms and legs
Eligibility
Children ages 3 months - 5 years with and without cerebral palsy
Design
Participants will be screened with
Physical exam
Questions for the parents about the child s health
Participants will have at least 1 study session Some may have up to 34 all optional
In the sessions participants will do motor tasks along with some or all of the following
Light sensors placed on the scalp held there with a cap or Velcro straps
Small metal disks placed on the scalp with a cap or straps with gel between them
Motion capture recording Balls attached to the arms and legs by stickers straps or a garment are tracked by infrared and video cameras
Motor tasks include reaching clapping kicking and standing
Participants may be placed in a toy or device that uses a motor to move their limbs
Participants head size hair and skin will be assessed
Parents will answer questions about their child s typical movements
New ways to study the brain as people move include near-infrared spectroscopy NIRS and electroencephalography EEG NIRS uses laser light shone through the scalp to look at blood flow in the brain which increases with movement EEG records electrical activity in the brain Little is known about brain activity while children learn new motor skills Researchers want to learn more about how small children with and without cerebral palsy use their brain to control their body This may help them find new ways to help children move better
Objectives
To learn more about how infants and young children with and without cerebral palsy use their brain to move their arms and legs
Eligibility
Children ages 3 months - 5 years with and without cerebral palsy
Design
Participants will be screened with
Physical exam
Questions for the parents about the child s health
Participants will have at least 1 study session Some may have up to 34 all optional
In the sessions participants will do motor tasks along with some or all of the following
Light sensors placed on the scalp held there with a cap or Velcro straps
Small metal disks placed on the scalp with a cap or straps with gel between them
Motion capture recording Balls attached to the arms and legs by stickers straps or a garment are tracked by infrared and video cameras
Motor tasks include reaching clapping kicking and standing
Participants may be placed in a toy or device that uses a motor to move their limbs
Participants head size hair and skin will be assessed
Parents will answer questions about their child s typical movements
Detailed Description:
OBJECTIVE
Portable neural imaging during functional tasks is now possible utilizing noninvasive near-infrared spectroscopy NIRS which identifies areas of brain activity by measuring blood flow dynamics and electroencephalography EEG which measures electrical activity on the cortical surface Use of these technologies for studying movement is rapidly increasing however investigations in children and those with neurological disorders such as cerebral palsy CP or autism spectrum disorder ASD are still in the early stages with few reports in the literature The objectives of this protocol are to systematically compare cortical activation patterns during specified sensorimotor tasks in infants and young children with typical development TD to those with and at high-risk for CP and ASD examine developmental changes in brain activation patterns that underlie the emergence of early functional or dysfunctional motor control and explore the neural and biomechanical effects of different devices that make movement easier for infants and toddlers with CP and ASD The results are expected to increase knowledge of brain activation patterns across tasks in groups with and without neurological disorders and to suggest potential mechanisms or strategies for future clinical intervention trials
STUDY POPULATION
The group with CP including all infants less than 18 months who are identified as being at high-risk for CP will consist of up to 100 children ages 3 months up to 5 years of age The group with ASD including all infants less than 3 years of age who are identified as being at high-risk for ASD will consist of up to 100 children ages 3 months up to 5 years of age The control group will consist of up to 100 children with TD within the same age range
DESIGN
This is an observational study that will include cross-sectional and longitudinal data collection NIRS andor EEG responses and kinematic andor kinetic force plate wearable sensors andor electromyography EMG recordings will be collected on all participants during the performance of self-initiated motor tasks Additionally we will evaluate brain and motor responses to devices that aim to make movement easier for infants and children who may have difficulty initiating or performing these movements without assistance
OUTCOME MEASURES
Primary outcomes are the magnitude extent and location of brain activity recorded by NIRS andor EEG within tasks across subject groups We will also quantify changes in brain activation across ages cross-sectional and time longitudinal Secondary outcomes may include motion force plate wearable sensors and EMG data to help interpret task and group differences and measures of motor abilities The same outcome measures will be compared across ages to examine the development of cortical activation patterns and motor abilities and how these change over time and across groups with and without neurological disorders
Portable neural imaging during functional tasks is now possible utilizing noninvasive near-infrared spectroscopy NIRS which identifies areas of brain activity by measuring blood flow dynamics and electroencephalography EEG which measures electrical activity on the cortical surface Use of these technologies for studying movement is rapidly increasing however investigations in children and those with neurological disorders such as cerebral palsy CP or autism spectrum disorder ASD are still in the early stages with few reports in the literature The objectives of this protocol are to systematically compare cortical activation patterns during specified sensorimotor tasks in infants and young children with typical development TD to those with and at high-risk for CP and ASD examine developmental changes in brain activation patterns that underlie the emergence of early functional or dysfunctional motor control and explore the neural and biomechanical effects of different devices that make movement easier for infants and toddlers with CP and ASD The results are expected to increase knowledge of brain activation patterns across tasks in groups with and without neurological disorders and to suggest potential mechanisms or strategies for future clinical intervention trials
STUDY POPULATION
The group with CP including all infants less than 18 months who are identified as being at high-risk for CP will consist of up to 100 children ages 3 months up to 5 years of age The group with ASD including all infants less than 3 years of age who are identified as being at high-risk for ASD will consist of up to 100 children ages 3 months up to 5 years of age The control group will consist of up to 100 children with TD within the same age range
DESIGN
This is an observational study that will include cross-sectional and longitudinal data collection NIRS andor EEG responses and kinematic andor kinetic force plate wearable sensors andor electromyography EMG recordings will be collected on all participants during the performance of self-initiated motor tasks Additionally we will evaluate brain and motor responses to devices that aim to make movement easier for infants and children who may have difficulty initiating or performing these movements without assistance
OUTCOME MEASURES
Primary outcomes are the magnitude extent and location of brain activity recorded by NIRS andor EEG within tasks across subject groups We will also quantify changes in brain activation across ages cross-sectional and time longitudinal Secondary outcomes may include motion force plate wearable sensors and EMG data to help interpret task and group differences and measures of motor abilities The same outcome measures will be compared across ages to examine the development of cortical activation patterns and motor abilities and how these change over time and across groups with and without neurological disorders
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-CC-0052 | None | None | None |