Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT03434080|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : October 2, 2019
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.
To learn more about how infants and young children with and without cerebral palsy use their brain to move their arms and legs.
Children ages 3 months - 5 years with and without cerebral palsy
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.
|Condition or disease|
|Autism Cerebral Palsy|
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 CR 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.
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.
This is an observational study that will include cross-sectional and longitudinal data collection. NIRS and/or EEG responses, and kinematic and/or kinetic, force plate, and/or 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.
Primary outcomes are the magnitude, extent and location of brain activity recorded by NIRS and/or 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 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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
|Actual Study Start Date :||May 16, 2018|
|Estimated Primary Completion Date :||December 1, 2025|
|Estimated Study Completion Date :||December 1, 2025|
Autism Spectrum Disorder
The group with ASD (including all infants less than 3 years of age who are identified as being at high-risk for ASD)
The group with CP (including all infants less than 18 months who are identified as being athigh-risk for CP)
Typical Development toddlers infants
The control group will consist of 50 healthy volunteers with TD
- Magnitude, extent and location of brain activity recorded by NIRS and/or EEG within tasks across subject groups. We will also quantify changes in brain activation across ages (cross-sectional) and time (longitudinal). [ Time Frame: each visit ]Data from each of the techniques will be compared across subjects group.
- Motion 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 ability. [ Time Frame: Each Visit ]Outcome measures quantified the type and extent of movement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434080
|Contact: Sara F Sadeghi||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Diane L Damiano, Ph.D.||National Institutes of Health Clinical Center (CC)|