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

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Feb 14, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how the brains of infants and toddlers use their muscles to move, specifically looking at children with and without cerebral palsy (CP) or autism spectrum disorder (ASD). The researchers want to understand brain activity during activities like reaching, clapping, and kicking, which may help improve movement skills in young children. They will use special tools to measure brain activity and blood flow while the children perform these tasks.

Children aged 3 months to 5 years, whether healthy or at risk for CP or ASD, may be eligible to participate. During the study, participants will undergo a physical exam and answer questions about their typical movements. They will take part in fun activities while wearing light sensors and motion tracking devices. Some children may have multiple study sessions, but this is optional. It’s important to note that certain health conditions or recent surgeries may exclude a child from participating, and the study team will discuss this during the screening process.

Gender

ALL

Eligibility criteria

• * INCLUSION 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
• 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).