AutismNCT03434080
Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy
An observational study of Autism and Cerebral Palsy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Cerebral Palsy
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2018to 21 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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).
Who may be able to join
- All subjects must be between age 3 months up to 5 years of age.
- A healthy volunteer, or
- A child with or at high risk for CP or ASD:
- An infant/child with an established diagnosis of CP, or
- An infant less than 18 months who has been identified by a physician as being at high risk for having CP, or
- An infant/child with an established diagnosis of ASD or
- A child less than 3 years of age who has been deemed at high-risk for ASD or developmental delays by a physician, early intervention specialist (enrolled in early intervention services), or other qualified health professional, or
- A younger sibling to a child diagnosed with ASD
Who cannot join
- Has any injury or health condition other than CP or ASD or being at-risk for having CP or ASD that affects the ability to move a body part repetitively for short periods. Examples include spinal cord injury, muscle diseases, congestive heart failure, or recently broken bones. The physician or other qualified health professioinal will discuss the child s health history during the screening to determine if participation is safe.
- Child of investigators and children of subordinates to an investigator
- Has a known genetic disorder that is a direct cause of the developmental delays
- Additional exclusion criteria for infants and young children with or at high risk for CP:
- Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl, dantrolene sodium, tizanidine, or carbidopa/levodopa).
- Has had surgery involving the musculoskeletal system (bone, joints, tendons, muscles, or neurological system (brain, spinal cord, peripheral nerves) within the past year
Show all 15Show fewer
- Botulinum toxin injections within the past four months.
- A history of having had a major seizure or now diagnosed as having a seizure disorder and is on medication for seizures (e.g. may have had a mild seizure(s) in the past but is not currently being treated for seizures).
- Chronic respiratory problems that require the use of oxygen.
- Additional exclusion criteria for infants and young children with or at high-risk for ASD:
- Has had surgery involving the musculoskeletal system (bone, joints, tendons, muscles, or neurological system (brain, spinal cord, peripheral nerves) within the past year.
- Has uncontrollable seizures (e.g. unable to be managed with medicines or treatment).
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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
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.
Read more
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.
...
Read the 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 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.
- Conditions
- Autism, Cerebral Palsy
- Keywords
- Infant and Toddler at Risk, Pediatric, Neuroimaging, Brain Function, Voluntary Movement, Natural History
- Medical subject headings
- Autistic Disorder, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| Cerebral Palsy | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: each visit
Secondary outcomes (1)
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.
Measured: Each Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start16 May 2018
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Why it stopped: PI Retirement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Diane L Damiano, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434080
- Sponsor's protocol ID
- 180052
- Other IDs
- 18-CC-0052
- Status last verified
- Aug 2025
- First submitted
- 14 Feb 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol is silent in IPD sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03434080
- Acronym / sponsor ID
- 180052
- Conditions
- Autism, Cerebral Palsy
- Keywords
- Infant and Toddler at Risk, Pediatric, Neuroimaging, Brain Function, Voluntary Movement, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI Retirement
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 16 May 2018 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
| Cerebral Palsy | – | –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 |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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).
Key inclusion criteria (8 listed)
- All subjects must be between age 3 months up to 5 years of age.
- A healthy volunteer, or
- A child with or at high risk for CP or ASD:
Key exclusion criteria (15 listed)
- Has any injury or health condition other than CP or ASD or being at-risk for having CP or ASD that affects the ability to move a body part repetitively for short periods. Examples include spinal cord injury, muscle diseases, congestive heart failure, or recently broken bones. The physician or other qualified health professioinal will discuss the child s health history during the screening to determine if participation is safe.
- Child of investigators and children of subordinates to an investigator
- Has a known genetic disorder that is a direct cause of the developmental delays
- Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl, dantrolene sodium, tizanidine, or carbidopa/levodopa).
- Has had surgery involving the musculoskeletal system (bone, joints, tendons, muscles, or neurological system (brain, spinal cord, peripheral nerves) within the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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...
Time frame: Each Visit
Results and safety
The study was stopped early (reason given: PI Retirement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Protocol is silent in IPD sharing.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane L Damiano, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Cerebral Palsy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI Retirement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.