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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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.


Condition or disease
Autism Cerebral Palsy

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 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.

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, 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 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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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)
Criteria
  • INCLUSION CRITERIA:
  • Age 3 months up to 5 years of age
  • A healthy volunteer, or
  • 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 is a younger sibling to a child diagnosed with ASD

EXCLUSION CRITERIA:

  • 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

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

  • 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).


Information from the National Library of Medicine

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


Contacts
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Contact: Sara F Sadeghi (301) 451-7529 sara.sadeghi@nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
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Principal Investigator: Diane L Damiano, Ph.D. National Institutes of Health Clinical Center (CC)

Additional Information:
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Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT03434080     History of Changes
Other Study ID Numbers: 180052
18-CC-0052
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 25, 2019
Keywords provided by National Institutes of Health Clinical Center (CC):
Infant and Toddler at Risk
Pediatric
Neuroimaging
Brain Function
Voluntary Movement
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases