Cerebral Palsy and the Study of Brain Activity During Motor Tasks

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Apr 9, 2013

Keywords

ClinConnect Summary

This clinical trial is studying how the brain controls movement in children with cerebral palsy compared to healthy children. Researchers will use two safe methods, near-infrared spectroscopy (NIRS) and electroencephalography (EEG), to see how the brain works while people are moving. By understanding the differences in brain activity between children with cerebral palsy and those without, the study aims to find new ways to help improve movement in children with this condition.

Children aged 5 and older who have cerebral palsy or who are healthy volunteers could be eligible to participate. Participants will undergo several tests, including brain scans and muscle activity measurements, and those with cerebral palsy will also have special sessions to help them learn how to better coordinate their movements and brain activity. It's important for participants to follow some guidelines before their sessions, like avoiding caffeine and alcohol for 24 hours. The goal is to make progress in understanding how to support children with cerebral palsy in improving their motor skills.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • Age 5 years of 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 (for adult participants or parent of child participants) or verbal/written assent (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.
• 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, myopathies, demyelinating conditions, 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.
• • 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.
• • Pregnancy: For any female of childbearing potential, a pregnancy test will be done. Childbearing potential will be determined during the history and physical.
• • Additional exclusion criteria for EEG
• • -History of allergic reaction to water-based electrode gel