Assessing brain activity during movement in young children with and without cerebral palsy
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 looks at how young children, both with and without cerebral palsy, use their brains to move by measuring their brain activity while they perform simple tasks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 3 Months to 5 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03434080 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how infants and toddlers, both with and without cerebral palsy, utilize their brains to control movement. Using advanced techniques like near-infrared spectroscopy (NIRS) and electroencephalography (EEG), researchers will measure brain activity and blood flow dynamics during motor tasks. The study will involve children aged 3 months to 5 years, with participants undergoing physical exams and optional study sessions to gather data on their brain activation patterns. The findings could provide insights into the neural mechanisms underlying motor control and inform future interventions for children with movement disorders.
Who should consider this trial
Good fit: Ideal candidates include infants and toddlers aged 3 months to 5 years, both with established diagnoses of cerebral palsy or autism and those identified as at high risk for these conditions.
Not a fit: Patients with other health conditions or injuries affecting movement, such as spinal cord injuries or muscle diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for helping children with cerebral palsy and autism develop better motor skills.
How similar studies have performed: While studies using NIRS and EEG in children are still emerging, this approach is relatively novel in the context of assessing motor control in young children with neurological disorders.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Diane L Damiano, Ph.D. — National Institutes of Health Clinical Center (CC)
- Study coordinator: Mayra J Medrano
- Email: mayra.medrano@nih.gov
- Phone: (301) 451-7529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.