Status:
TERMINATED
Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Autism
Cerebral Palsy
Eligibility:
All Genders
3-5 years
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 ...
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 dyna...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
May 16 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03434080
Start Date
May 16 2018
End Date
August 21 2025
Last Update
August 22 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892