TERMINATED

Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy

Conditions

Autism Cerebral Palsy Infant and Toddler at Risk Pediatric Neuroimaging Brain Function Voluntary Movement Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

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

Quick Facts

Study Start:2018-05-16

Study Completion:2025-08-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT03434080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 5 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* 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	* 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 * 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. * 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).

Inclusion Criteria

Exclusion Criteria

* 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

* 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
* 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.
* 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).

Contacts and Locations

Principal Investigator

Diane L Damiano, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-16

Study Completion Date2025-08-21

Study Record Updates

Study Start Date2018-05-16

Study Completion Date2025-08-21

Terms related to this study

Keywords Provided by Researchers

Infant and Toddler at Risk
Pediatric
Neuroimaging
Brain Function
Voluntary Movement
Natural History

Additional Relevant MeSH Terms

Autism
Cerebral Palsy