An observational study in Autism and Cerebral Palsy, sponsored by National Institutes of Health Clinical Center (CC). Terminated at 1 site in United States. Open to participants aged 3 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by National Institutes of Health Clinical Center (CC) · Observational
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:
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:
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.
...
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 and/or EEG responses, and kinematic and/or kinetic, force plate, wearable sensors, 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.
OUTCOME MEASURES
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, 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.
1. patient diagnosed with Autism or infant at high risk ASD. 2. patient diagnosed with CP or infant under 18 months for being at high risk with CP. 3. Typical Development kids (TD).
A child with or at high risk for CP or ASD:
EXCLUSION CRITERIA:
Additional exclusion criteria for infants and young children with or at high risk for CP:
Additional exclusion criteria for infants and young children with or at high-risk for ASD:
Additional exclusion criteria for infants and young children with TD
-Born preterm (defined as less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for
gestational age).
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)
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).
Data from each of the techniques will be compared across subjects group.
Time frame: each visit
Secondary outcomes include 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 mo...
Outcome measures quantified the type and extent of movement.
Time frame: Each Visit
Plan to share: Undecided — Protocol is silent in IPD sharing.
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institutes of Health Clinical Center (CC)