Near-infrared Spectroscopy and Electroencephalography to Assess Cortical Activation During Motor Tasks in Infants and Toddlers With and Without Cerebral Palsy
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any - 5 |
| Updated: | 1/10/2019 |
| Start Date: | May 16, 2018 |
| End Date: | December 1, 2025 |
| Contact: | Sara F Sadeghi |
| Email: | sara.sadeghi@nih.gov |
| Phone: | (301) 451-7529 |
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 in the brain which increases with movement. EEG records electrical activity in the
brain. Little is known about brain activity while children learn new motor skills.
Researchers want to learn more about how small children with and without cerebral palsy use
their brain to control their body. This may help them find new ways to help children move
better.
Objectives:
To learn more about how infants and young children with and without cerebral palsy use their
brain to move their arms and legs.
Eligibility:
Children ages 3 months - 5 years with and without cerebral palsy
Design:
Participants will be screened with:
- Physical exam
- Questions for the parents about the child s health
Participants will have at least 1 study session. Some may have up to 34 (all optional).
In the sessions, participants will do motor tasks along with some or all of the following:
- Light sensors placed on the scalp, held there with a cap or Velcro straps.
- Small metal disks placed on the scalp with a cap or straps, with gel between them.
- Motion capture recording. Balls attached to the arms and legs by stickers, straps, or a
garment are tracked by infrared and video cameras.
Motor tasks include reaching, clapping, kicking, and standing.
Participants may be placed in a toy or device that uses a motor to move their limbs.
Participants head size, hair, and skin will be assessed.
Parents will answer questions about their child s typical movements.
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 in the brain which increases with movement. EEG records electrical activity in the
brain. Little is known about brain activity while children learn new motor skills.
Researchers want to learn more about how small children with and without cerebral palsy use
their brain to control their body. This may help them find new ways to help children move
better.
Objectives:
To learn more about how infants and young children with and without cerebral palsy use their
brain to move their arms and legs.
Eligibility:
Children ages 3 months - 5 years with and without cerebral palsy
Design:
Participants will be screened with:
- Physical exam
- Questions for the parents about the child s health
Participants will have at least 1 study session. Some may have up to 34 (all optional).
In the sessions, participants will do motor tasks along with some or all of the following:
- Light sensors placed on the scalp, held there with a cap or Velcro straps.
- Small metal disks placed on the scalp with a cap or straps, with gel between them.
- Motion capture recording. Balls attached to the arms and legs by stickers, straps, or a
garment are tracked by infrared and video cameras.
Motor tasks include reaching, clapping, kicking, and standing.
Participants may be placed in a toy or device that uses a motor to move their limbs.
Participants head size, hair, and skin will be assessed.
Parents will answer questions about their child s typical movements.
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 dynamics and electroencephalography (EEG) which measures electrical activity on the
cortical surface. Use of these technologies for studying movement is rapidly increasing;
however, investigations in children and those with brain injuries such as cerebral palsy are
still in the early stages with few reports in the literature. The objectives of this protocol
are to systematically compare cortical activation patterns during specified sensorimotor
tasks in healthy infants and young children to those with cerebral palsy, examine
developmental changes in brain activation patterns that underlie the emergence of early
functional or dysfunctional motor control and explore the neural and biomechanical effects of
different devices that make movement easier for infants and toddlers with cerebral palsy. The
results are expected to increase knowledge of brain activation patterns across tasks and
groups with and without brain injuries and to suggest potential mechanisms or strategies for
future clinical intervention trials.
STUDY POPULATION
The group with cerebral palsy (including all infants less than 18 months who are identified
as being at high-risk for CP) will consist of up to 100 children ages 3 months up to 5 years
of age. The control group will consist of 50 healthy volunteers within the same age range.
DESIGN
This is an observational study that will include cross-sectional and longitudinal data
collection. NIRS and/or EEG responses, and kinematic and/or electromyography (EMG) recordings
will be collected on all participants during the performance of self-initiated motor tasks.
Additionally, we will evaluate brain and motor responses to devices that aim to make movement
easier for infants and children with motor disabilities who may have difficulty initiating or
performing these movements without assistance.
OUTCOME MEASURES
Primary outcomes are the magnitude, extent and location of brain activity recorded by NIRS
and/or EEG within tasks across subject groups. We will also quantify changes in brain
activation across ages (cross-sectional) and time (longitudinal).
Secondary outcomes include motion and EMG data to help interpret task and group differences
and measures of motor abilities. The same outcome measures will be compared across ages to
examine the development of cortical activation patterns and motor abilities and how these
change over time and across groups.
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 dynamics and electroencephalography (EEG) which measures electrical activity on the
cortical surface. Use of these technologies for studying movement is rapidly increasing;
however, investigations in children and those with brain injuries such as cerebral palsy are
still in the early stages with few reports in the literature. The objectives of this protocol
are to systematically compare cortical activation patterns during specified sensorimotor
tasks in healthy infants and young children to those with cerebral palsy, examine
developmental changes in brain activation patterns that underlie the emergence of early
functional or dysfunctional motor control and explore the neural and biomechanical effects of
different devices that make movement easier for infants and toddlers with cerebral palsy. The
results are expected to increase knowledge of brain activation patterns across tasks and
groups with and without brain injuries and to suggest potential mechanisms or strategies for
future clinical intervention trials.
STUDY POPULATION
The group with cerebral palsy (including all infants less than 18 months who are identified
as being at high-risk for CP) will consist of up to 100 children ages 3 months up to 5 years
of age. The control group will consist of 50 healthy volunteers within the same age range.
DESIGN
This is an observational study that will include cross-sectional and longitudinal data
collection. NIRS and/or EEG responses, and kinematic and/or electromyography (EMG) recordings
will be collected on all participants during the performance of self-initiated motor tasks.
Additionally, we will evaluate brain and motor responses to devices that aim to make movement
easier for infants and children with motor disabilities who may have difficulty initiating or
performing these movements without assistance.
OUTCOME MEASURES
Primary outcomes are the magnitude, extent and location of brain activity recorded by NIRS
and/or EEG within tasks across subject groups. We will also quantify changes in brain
activation across ages (cross-sectional) and time (longitudinal).
Secondary outcomes include motion and EMG data to help interpret task and group differences
and measures of motor abilities. The same outcome measures will be compared across ages to
examine the development of cortical activation patterns and motor abilities and how these
change over time and across groups.
- INCLUSION CRITERIA:
- Age 3 months up to 5 years of age
- A healthy volunteer or
- 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.
EXCLUSION CRITERIA:
- Has any injury or health condition other than CP or being at high risk for having CP
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 will discuss the child s health history during the
screening to determine if participation is safe.
- (for EEG) A history of allergic reaction to water-based electrode gel.
Additional exclusion criteria for infants and young children with CP
- Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl,
dantrolene sodium, tizanidine, or carbidopa/levodopa).
- Surgery within the past year or 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.
- Children of investigators and children of subordinates to an investigator.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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