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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-CC-0052

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 mo
Max Age: 5

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Infant and Toddler at Risk;
Pediatric;
Neuroimaging;
Brain Function;
Voluntary Movement

Recruitment Keyword(s)

None

Condition(s)

Autism;
Cerebral Palsy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

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 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

-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).


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Diane L. Damiano, Ph.D.
National Institutes of Health Clinical Center (CC)



Ingrid M. Vasquez
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7529
ingrid.vasquez@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03434080

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