Cerebral Palsy and the Study of Brain Activity During Motor Tasks
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/10/2019 |
| Start Date: | April 9, 2013 |
| End Date: | October 8, 2025 |
| Contact: | Sara F Sadeghi |
| Email: | sara.sadeghi@nih.gov |
| Phone: | (301) 451-7529 |
Near-infrared Spectroscopy and Electroencephalography to Assess and Train Cortical Activation During Motor Tasks
Background:
- Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS)
and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it
is active. EEG records electrical activity in the brain. Both have been used safely for many
years, even in very young children. NIRS or EEG can be used while a person is moving to show
which parts of the brain are the most active. Researchers want to use NIRS and EEG to study
brain activity during movement in people with cerebral palsy and healthy volunteers. Learning
more about how people with and without cerebral palsy use their brain to control their
muscles may lead to new ways of training people with cerebral palsy to move better.
Objectives:
- To study how the brain controls body movement in people with and without cerebral palsy.
Eligibility:
- Individuals at least 5 years of age who have cerebral palsy.
- Healthy volunteers at least 5 years of age.
Design:
- This study has three parts. People with cerebral palsy will be selected for all three.
Healthy volunteers will be asked to do only two of them. Everyone who participates will
have NIRS and/or EEG exams during movement. People with cerebral palsy may also have
biofeedback sessions to train coordination of movement and brain activity.
- Participants will be screened with a physical exam and medical history. Urine samples
may be collected.
- All participants will have at least one session of NIRS and/or EEG imaging studies.
Sessions may also include the following tests:
- Magnetic resonance imaging to look at the brain
- Electromyography to measure electrical activity of the muscles
- Motion analysis of specific body parts
- Ultrasound to measure activity of the muscles
- Motorized, robotic, and electrical stimulation of the muscles
- Other clinical tests of muscle movement as needed.
- Participants with cerebral palsy will have biofeedback sessions. These sessions will
help them learn to coordinate muscle movement and brain activity.
- Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS)
and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it
is active. EEG records electrical activity in the brain. Both have been used safely for many
years, even in very young children. NIRS or EEG can be used while a person is moving to show
which parts of the brain are the most active. Researchers want to use NIRS and EEG to study
brain activity during movement in people with cerebral palsy and healthy volunteers. Learning
more about how people with and without cerebral palsy use their brain to control their
muscles may lead to new ways of training people with cerebral palsy to move better.
Objectives:
- To study how the brain controls body movement in people with and without cerebral palsy.
Eligibility:
- Individuals at least 5 years of age who have cerebral palsy.
- Healthy volunteers at least 5 years of age.
Design:
- This study has three parts. People with cerebral palsy will be selected for all three.
Healthy volunteers will be asked to do only two of them. Everyone who participates will
have NIRS and/or EEG exams during movement. People with cerebral palsy may also have
biofeedback sessions to train coordination of movement and brain activity.
- Participants will be screened with a physical exam and medical history. Urine samples
may be collected.
- All participants will have at least one session of NIRS and/or EEG imaging studies.
Sessions may also include the following tests:
- Magnetic resonance imaging to look at the brain
- Electromyography to measure electrical activity of the muscles
- Motion analysis of specific body parts
- Ultrasound to measure activity of the muscles
- Motorized, robotic, and electrical stimulation of the muscles
- Other clinical tests of muscle movement as needed.
- Participants with cerebral palsy will have biofeedback sessions. These sessions will
help them learn to coordinate muscle movement and brain activity.
Objective:
Neural imaging during functional tasks has become more portable and accessible than magnetic
resonance imaging (MRI) by utilizing non-invasive near-infrared spectroscopy (NIRS) as a
means to isolate areas of brain activity by measuring blood flow dynamics and
electroencephalography (EEG) to measure electrical activity on the cortical surface. Although
use of these technologies for assessing cortical activation patterns is increasing,
validation of these approaches, particularly in children and those with brain injuries such
as cerebral palsy, is in the early stages with few reports in the literature. The use of
these in motor training paradigms for rehabilitation populations has not yet been reported.
The objectives of this protocol are to: 1) systematically compare cortical activation
patterns associated with specified motor and sensory tasks in healthy children and adults to
those with unilateral or bilateral childhood-onset brain injury; 2) extend the use of EEG in
our laboratory across subject groups and tasks, when used alone or with NIRS; and 3) pilot
the use of NIRS and/ or EEG as a brain biofeedback device in children with childhood-onset
brain injury. The first two objectives are observational only, the third objective includes a
pilot intervention. The results of this study are expected to increase knowledge of brain
activation patterns across tasks and groups with and without brain injuries and to provide
proof of concept and power estimates for future clinical studies with these technologies. A
secondary question we would like to examine with these imaging technologies is the potential
effect of motor impairments resulting from childhood-onset peripheral injuries (e.g.
obstetrical brachial plexus palsy) on brain reorganization.
Study population:
The childhood-onset brain injury group will consist of up to120 individuals (5 years and
above) spanning the three objectives. The childhood-onset peripheral injury group will
consist of up to 100 individuals within the same age-range spanning only Objectives 1 and 2.
The control groups for each participant cohort will consist of up to 50 individuals spanning
Objectives 1 and 2, for a total recruitment of up to 100 healthy volunteers within the same
age range.
Design:
Objective 1, the primary focus of this research protocol, is a cross-sectional analysis of
multiple tasks across subject groups. Objective 2 is primarily a descriptive study, and
Objective 3 is a pilot evaluation of the effectiveness of novel short term motor training
program in children with childhood-onset brain injury targeted at improving brain activation
patterns and motor performance.
Outcome measures:
Objective 1 is the primary quantitative objective in this protocol, in which we will compare
location, magnitude, volume and area of cortical activation across tasks and groups.
Secondary outcomes include descriptive measures that will be used primarily to evaluate the
two techniques or to monitor motion and muscle activation (EMG and ultrasound) data to help
interpret task and group differences. Objective 3 will measure changes in brain activation
and motor performance in childhood-onset brain injury before and after a short training
program.
Neural imaging during functional tasks has become more portable and accessible than magnetic
resonance imaging (MRI) by utilizing non-invasive near-infrared spectroscopy (NIRS) as a
means to isolate areas of brain activity by measuring blood flow dynamics and
electroencephalography (EEG) to measure electrical activity on the cortical surface. Although
use of these technologies for assessing cortical activation patterns is increasing,
validation of these approaches, particularly in children and those with brain injuries such
as cerebral palsy, is in the early stages with few reports in the literature. The use of
these in motor training paradigms for rehabilitation populations has not yet been reported.
The objectives of this protocol are to: 1) systematically compare cortical activation
patterns associated with specified motor and sensory tasks in healthy children and adults to
those with unilateral or bilateral childhood-onset brain injury; 2) extend the use of EEG in
our laboratory across subject groups and tasks, when used alone or with NIRS; and 3) pilot
the use of NIRS and/ or EEG as a brain biofeedback device in children with childhood-onset
brain injury. The first two objectives are observational only, the third objective includes a
pilot intervention. The results of this study are expected to increase knowledge of brain
activation patterns across tasks and groups with and without brain injuries and to provide
proof of concept and power estimates for future clinical studies with these technologies. A
secondary question we would like to examine with these imaging technologies is the potential
effect of motor impairments resulting from childhood-onset peripheral injuries (e.g.
obstetrical brachial plexus palsy) on brain reorganization.
Study population:
The childhood-onset brain injury group will consist of up to120 individuals (5 years and
above) spanning the three objectives. The childhood-onset peripheral injury group will
consist of up to 100 individuals within the same age-range spanning only Objectives 1 and 2.
The control groups for each participant cohort will consist of up to 50 individuals spanning
Objectives 1 and 2, for a total recruitment of up to 100 healthy volunteers within the same
age range.
Design:
Objective 1, the primary focus of this research protocol, is a cross-sectional analysis of
multiple tasks across subject groups. Objective 2 is primarily a descriptive study, and
Objective 3 is a pilot evaluation of the effectiveness of novel short term motor training
program in children with childhood-onset brain injury targeted at improving brain activation
patterns and motor performance.
Outcome measures:
Objective 1 is the primary quantitative objective in this protocol, in which we will compare
location, magnitude, volume and area of cortical activation across tasks and groups.
Secondary outcomes include descriptive measures that will be used primarily to evaluate the
two techniques or to monitor motion and muscle activation (EMG and ultrasound) data to help
interpret task and group differences. Objective 3 will measure changes in brain activation
and motor performance in childhood-onset brain injury before and after a short training
program.
- INCLUSION CRITERIA
- Age 5 years of older
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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