Studying brain activity during movement in children with cerebral palsy
Near-infrared Spectroscopy and Electroencephalography to Assess and Train Cortical Activation During Motor Tasks
This study looks at how the brains of children with cerebral palsy work during movement compared to healthy kids to see if it can help improve their movement skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 5 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01829724 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how the brain controls body movement in children with cerebral palsy compared to healthy volunteers. Utilizing non-invasive techniques like near-infrared spectroscopy (NIRS) and electroencephalography (EEG), researchers will measure brain activity during motor tasks. The study will systematically compare brain activation patterns between the two groups and explore the potential of using these technologies for rehabilitation. The findings may lead to improved training methods for children with cerebral palsy to enhance their movement abilities.
Who should consider this trial
Good fit: Ideal candidates include children aged 5 years and older with a diagnosis of cerebral palsy or healthy volunteers of the same age.
Not a fit: Patients who have had surgery in the last six months or received botulinum toxin injections in the last four months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new training techniques that improve motor function in children with cerebral palsy.
How similar studies have performed: While the use of NIRS and EEG in this context is still emerging, similar studies have shown promise in understanding brain activity during movement.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA * Age 5 years and older * Surgery free for six months in either the upper or lower extremities. * Free from botulinum toxin injections within four months in either the upper or lower extremities. * Either a healthy volunteer or have a diagnosis of a childhood-onset (before 13 years of age) brain injury resulting in motor impairment of one arm and one leg on the same side of the body or motor impairment of both legs or have a diagnosis of childhood-onset (before 13 years of age) peripheral injury resulting in sensory or motor impairment of any limb or multiple limbs. * Able to understand and follow simple directions that include how to perform a repetitive task and when to start and stop doing the task, based on parent report if the subject is a child and physician observation during history and physical examination. * Able to walk at least 20 feet without stopping with or without a walking aid * Able to provide informed consent (Guardian or parent of child participants) or verbal/written assent as appropriate (for child participant). * Agreement to not drink caffeine or alcohol for 24 hours before each assessment session because both agents can modify brain activity and may confound outcome measures. This restriction does not apply to the training sessions in Objective 3. EXCLUSION CRITERIA: * Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than childhood-onset brain or peripheral injury that would affect the ability to mentally concentrate or move a body part repetitively for short periods of time. Examples of this include, but are not limited to, congestive heart failure, end stage cardiac disease, or fractures that have not completely healed. * Uncontrolled seizures. * Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl, dantrolene sodium, tizanidine, or carbidopa/levodopa). If patients are taking these medications daily, the treating physician will be contacted by the MAI to determine if it is acceptable for the subject to temporarily discontinue the medication(s) for 24 hours prior to participating in testing for this study for each of the first 2 objectives. If that is not deemed to be safe, the subject will be excluded. Subjects who are on these medications will not be allowed to participate in Objective 3. * Pregnancy: Childbearing potential will be determined during the history and physical exam and urine pregnancy test may be required * Adult who can t consent for themselves. To participate in Objective 1, it is preferable that all subjects be willing and able to have, or have previously had, a structural MRI to aid in the interpretation of results. Inability or refusal to complete an MRI, or to provide access to a previous structural MRI scan, will not constitute an exclusion criterion for this study. Additional exclusion criteria for MRI * Inability to lie flat on the back for up to 45 minutes without sedation. * Discomfort being in small spaces for up to 45 minutes. * Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth that cannot be safely removed. Additional exclusion criteria for EEG -History of allergic reaction to water-based electrode gel
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Thomas C Bulea, Ph.D. — National Institutes of Health Clinical Center (CC)
- Study coordinator: Functional & Applied Biomechanics Sectio
- Email: ccrmdfab@mail.nih.gov
- Phone: (301) 412-5989
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.