Perinatal Stroke: Understanding Brain Reorganization
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/28/2018 |
| Start Date: | May 2016 |
| End Date: | June 2019 |
| Contact: | Maureen E Boxrud, BA |
| Email: | brown029@umn.edu |
| Phone: | 612-626-6415 |
Perinatal Stroke: Understanding Brain Reorganization Through Infant Neuroimaging and Neuromodulation
The incidence of perinatal stroke is relatively common, as high as 1 in 2,300 births, but
little is known about the resulting changes in the brain that eventually manifest as cerebral
palsy (CP). More importantly, no therapy has been devised to mitigate these specific
maladaptive changes leading to hemiplegic CP. However, motor signs that indicate the infant
is beginning to develop CP often do not become evident for several months after the diagnosis
of perinatal stroke. This delays therapy. We view the first several months after perinatal
stroke as a "window of opportunity" because it is known to be a critical period of
development. During this period, a well-designed intervention could minimize maladaptive
changes in the brain. To design such a science-based rehabilitation protocol for young
infants during this window of opportunity, we must first develop efficient and reliable
assessments to detect and measure maladaptive cortical reorganization in the brain.
Therefore, the main purpose of this study is to examine early brain reorganization in infants
3-12 months of age corrected for prematurity with perinatal stroke using magnetic resonance
imaging (MRI) and non-invasive transcranial magnetic stimulation (TMS). In addition, the
association between the brain reorganization and motor outcomes of these infant participants
will be identified.
In this study, the MRI scans will include diffusion tensor imaging (DTI) - an established
method used to investigate the integrity of pathways in the brain that control limb movement.
Infants will be scanned during nature sleeping after feeding. The real scanning time will be
less than 38 minutes. TMS is a painless, non-surgical brain stimulation device which uses
principles of electromagnetic induction to excite cortical tissue from outside the skull.
Using TMS as a device to modulate and examine cortical excitability in children with
hemiparetic CP and in adults has been conducted previously. In this infant study, we will
assess cortical excitability from the motor cortex of both the ipsilesional and
contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation
system. Additionally, the investigators will assess infants' movement quality using an
age-appropriate standardized movement assessment. This will allow the investigators to
examine the relationship between measures of motor pathway integrity and early signs of
potential motor impairment.
We will longitudinally follow enrolled infants up to 24 months of age corrected for
prematurity, and complete repeat assessments at 12 and 24 months corrected age to assess how
infants develop over time after perinatal stroke.
little is known about the resulting changes in the brain that eventually manifest as cerebral
palsy (CP). More importantly, no therapy has been devised to mitigate these specific
maladaptive changes leading to hemiplegic CP. However, motor signs that indicate the infant
is beginning to develop CP often do not become evident for several months after the diagnosis
of perinatal stroke. This delays therapy. We view the first several months after perinatal
stroke as a "window of opportunity" because it is known to be a critical period of
development. During this period, a well-designed intervention could minimize maladaptive
changes in the brain. To design such a science-based rehabilitation protocol for young
infants during this window of opportunity, we must first develop efficient and reliable
assessments to detect and measure maladaptive cortical reorganization in the brain.
Therefore, the main purpose of this study is to examine early brain reorganization in infants
3-12 months of age corrected for prematurity with perinatal stroke using magnetic resonance
imaging (MRI) and non-invasive transcranial magnetic stimulation (TMS). In addition, the
association between the brain reorganization and motor outcomes of these infant participants
will be identified.
In this study, the MRI scans will include diffusion tensor imaging (DTI) - an established
method used to investigate the integrity of pathways in the brain that control limb movement.
Infants will be scanned during nature sleeping after feeding. The real scanning time will be
less than 38 minutes. TMS is a painless, non-surgical brain stimulation device which uses
principles of electromagnetic induction to excite cortical tissue from outside the skull.
Using TMS as a device to modulate and examine cortical excitability in children with
hemiparetic CP and in adults has been conducted previously. In this infant study, we will
assess cortical excitability from the motor cortex of both the ipsilesional and
contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation
system. Additionally, the investigators will assess infants' movement quality using an
age-appropriate standardized movement assessment. This will allow the investigators to
examine the relationship between measures of motor pathway integrity and early signs of
potential motor impairment.
We will longitudinally follow enrolled infants up to 24 months of age corrected for
prematurity, and complete repeat assessments at 12 and 24 months corrected age to assess how
infants develop over time after perinatal stroke.
Background and Significance
Perinatal stroke affects more than1 in 2,300 live births. Perinatal stroke is the most common
cause of hemiparetic cerebral palsy (CP). Even with prompt behavioral therapy, ongoing
significant residual motor impairments are common in these children. In this case, innovative
interventions that take advantage of the early critical window for optimizing outcomes are
urgently needed—in infancy. Thus, understanding the early brain reorganization before the
brain has not yet largely reorganized is critical for developing efficacious early
intervention.
Current pediatric studies have employed non-invasive brain stimulation, and most commonly use
the single or paired-pulses of Transcranial Magnetic Stimulation (TMS) to evaluate brain
plasticity by assessing cortical excitability. To date, there is only one infant study using
TMS to assess cortical excitability with perinatal stroke. As a unique aspect of
investigation, this study will combine Magnetic Resonance Imaging (MRI)/ Diffusion Tensor
Imaging (DTI) and TMS to provide an additional opportunity to assess both the cortical
excitability and corticospinal tract (CST) integrity in infants with perinatal stroke.
Identifying the association between laboratory assessment results and developmental outcomes
is also critical. The General Movements Assessment (GMA) is a quick and non-invasive way to
evaluate motor performance and to predict CP in high-risk infants before 20 weeks of age
(corrected age for preterm infants). The BSID-III is a standardized, norm-referenced
developmental assessment validated for use for children 1-42 months of age to assess motor
function. Thus, the purpose of this study is to use MRI/DTI and TMS to comprehensively
examine both the CST integrity and cortical excitability in infants following perinatal
stroke, and to identify association with motor outcome as evaluated by movement assessment
Specific Aims/Study Objectives
Aim 1: Use TMS to index maladaptive cortical reorganization by assessing the relative
excitability of corticospinal projections from each hemisphere to upper extremity musculature
in 3 to 24 month old children who have a confirmed diagnosis of perinatal stroke.
Hypothesis: The ipsilesional hemisphere will have a smaller "map volume" (lower cortical
excitability) than the contralesional hemisphere (larger map volume).
Aim 2: Index maladaptive cortical reorganization by evaluating the organizational integrity
of the CSTs bilaterally via fractional anisotropy (FA), a standardized metric derived from
DTI, in infants with perinatal stroke.
Hypothesis 1: Ipsilesional CST will have a lower value of FA than the contralesional CST.
Hypothesis 2: Smaller cortical excitability volumes will be associated with lower values of
FA.
Aim 3: For infants with perinatal stroke, examine the relationship between movement quality
derived from the movement assessment and cortical excitability and with CST integrity.
Hypothesis: Atypical movement assessment outcome scores will be associated with a lower FA
value and lower ipsilesional CST excitability.
Aim 4: Record any feasibility issues that arise, and monitor for adverse events during TMS
cortical mapping and MRI scanning of infants with perinatal stroke.
Hypothesis 1: TMS and MRI assessments of infants with perinatal stroke are feasible.
Hypothesis 2: No seizure or other serious adverse event related to TMS or MRI/DTI will occur
in this study.
Research Design and Methods
Study design and sample size: This study will be a cross-sectional, two-visit pilot study
with MRI scanning on Visit 1, and TMS and movement assessment testing on the Visit 2. Thirty
term or preterm infants between 3 and 12 months of age corrected for prematurity with the
diagnosis of perinatal stroke will be enrolled.
Subjects Recruitment Plan:
Stage 1: For families who contact the investigators with interest in this study after seeing
the recruitment letter or flyer, initial screening process will be completed. This includes
review of medical records obtained by signatures on an authorization form to list the clinics
to be contacted for medical records.
Stage 2: Once the investigators have determined eligibility for study criteria for the
infant, they will mail the family the consent and HIPAA for review, follow-up with a phone
call to discuss any questions and then schedule a consent meeting to discuss and obtain
signatures. If the family deems appropriate, this can occur on the same day as Visit 1.
Procedures
Visit 1 (MRI/DTI)
Preparatory Activity:
One week prior to Visit 1, the study team will educate caregivers as to how to prepare the
infant for the optimal MRI experience. Caregivers will receive a digital file with a
recording of the MRI operation sound. The caregivers will be asked to play these sounds while
the infant sleeps so they become familiarized with these noises.
Day of Visit:
Infants will be fed, by their caregiver in a separate calming room, and then allowed to fall
asleep for MRI scanning. A memory foam mattress for infants will be used to support them
firmly and comfortably on the scanner table. Both silicone infant ear plugs and ear protector
will both be used to diminish the noises during scanning. One researcher will stay with the
infants throughout the scanning session to ensure and monitor infants' responses and safety.
Subjects will be scanned on a Siemens 3Tesla (magnet strength) system at the Center for
Magnetic Resonance Research (CMRR).
The scan protocol will include both an anatomical T1-weighted structural MPRAGE scan with
spatial resolution 1x1x1mm3 that will be used to guide the TMS testing in Aim 2 and DTI which
will allow investigation of the variation in connectivity of the CST in these infants with
perinatal stroke. High angular resolution diffusion imaging (HARDI) with whole-brain coverage
using the 'Human Connectome Project' (HCP) DTI sequence and spatial resolution
1.8x1.8x1.8mm3, b-value=1500 s/mm2, 128 gradient directions and 15 additional non-diffusion
weighted images will be obtained. HCP tractographic methods will be applied to the HARDI data
to define the two CST's and compute the integrity metrics of track volume and mean fractional
anisotropy (FA). The complete MRI dataset will be obtained in less than 38 minutes.
Visit 2 (Movement Assessment and TMS):
Visit 2 will be scheduled within 7 days after Visit 1 to avoid nonsynchronous results of
MRI/DTI and TMS due to natural developmental changes of central nervous system.
Movement Assessment:
For GMA scoring, infants will be placed in supine position wearing only a diaper to allow for
clear observation of trunk and limbs spontaneous movements. Infants will be observed and
videotaped for 5-10 minutes in an awake but calm state without interacting with people around
them or while playing with a toy. The classifications of "typical" and "atypical" of
different movement categories of GMA will be determined to define the ranks of motor outcomes
in each infant.
The BSID-III motor scales will be administered and scored by a pediatric physical therapist.
This assessment will take approximately 30-45 minutes to complete and involves assessing a
child's natural movements and interactions with toys and objects. The BSID-III is a
norm-referenced assessment that allows comparison of scores to typically developing age
matched peers.
TMS:
Single-pulse TMS (Bistim2, Magstim, UK) with a 50mm figure-of-eight coil (P/N4186-00,Magstim,
UK) will be used to assess cortical excitability from the M1 region of both the ipsilesional
and contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation
system (Brainsight, Rogue Research, Montreal, Quebec, Canada). Each infant's MRI will be
projected onto the neuronavigation system to assist with localization of the motor cortex (T1
MPRage).
Mapping (10 minutes): A 5-by-5 cortical grid of target (25 targets in total) with the
interval 1 cm (4X4 cm2) will be generated over the motor cortex area in the Neuronavigation
System. A response map based on the peak-to-peak amplitude of MEP will be created in real
time by a customized program (LabVIEW, v2012, National Instruments, Austin, TX) program.
Hotspot determination and motor threshold determination (15 minutes): The target with the
greatest motor evoke potential (MEP) peak-to-peak amplitude will be defined as the hotspot
which is the most responsive location on the motor cortex. After determining the hotspot, the
motor threshold (MT) will be assessed over the hotspot. We define the resting MT as the
minimal TMS output necessary to produce MEPs with a peak-to-peak amplitude >50 microvolts in
at least 3 out of 5 consecutive trials. EMG signal will be recorded using surface
electromyography (EMG) electrodes attached over bilateral biceps based. All data will be
collected by a custom EMG amplifier and data acquisition system and stored by LabVIEW program
(National Instruments, Austin, TX) for offline analysis.
Anticipated Risks/Risk Mitigation:
MRI-Dislodging of indwelling metals and disruption of medical devices: Exclude if
metal/medical devices are incompatible.
MRI-Metal projectiles inadvertently presented during MRI: Conduct on-site screen and removal
of potential projectiles (coins, keys, etc).
MRI-Temporary mild hearing loss due to noise level of equipment: Subjects will wear earplugs
(~20 decibel reduction) and headphones (~35 dB reduction) during MRI to protect against
excessive noise MRI-Discomfort due to positioning: Investigator to be present in MRI room
throughout the scan with visual and tactile monitoring MRI-Wake up and move during the MRI
scanning: One investigator will stay with the infants throughout the scanning process to
monitor infants' arousal state and secure the infants if the infants are fully awake
TMS-Stimulation over a tumor which may alter metabolic activity: Screen appropriately for
exclusion criteria of neoplasm.
TMS-Threshold altering pharmacologic agent: Physician review of each medical record for
determination of appropriateness for study inclusion.
TMS-Pain: Age-appropriate Vital signs (HR, RR and BP), skin integrity, distress responses
will be continuously monitored for determination of pausing or stopping.
TMS-Fatigue, Sleepiness: Infant arousal state will be monitored and recorded each minute
during the TMS test TMS-Temporary mild hearing loss due to noise level of equipment: Silicon
infant-appropriate ear plugs will be inserted before TMS and continuously checked for
placement.
TMS-Safe practices will be further ensured by establishing the location for testing within
the University of Minnesota's Clinical and Translational Science Institute (CTSI), where the
equipment and personnel to manage a seizure or other complications are present if an adverse
event occurs, the protocol will be following and the infant will be assessed and the study
reviewed for safety.
TMS-No serious adverse events have been reported from the few published studies investigating
TMS in infants. As the innovation of this study is to investigate comprehensively both the
safety and feasibility of TMS and neuroimaging in infant, we have devised complete individual
and entire study stopping rules.
GMA-Concern for facial recognition and loss of anonymity: The recording will be destroyed
after it is coded, up to 5 years after the completion of the study. This recording will not
be used for any purposes outside of the research study.
Follow up assessments will be repeated at 12 and 24 months of age corrected for prematurity.
The investigators will incorporate a follow-up phone call 1-month after participation to
continue the assessment of safety. Questions pertaining to change in medical status,
including any onset of seizures will be asked.
Perinatal stroke affects more than1 in 2,300 live births. Perinatal stroke is the most common
cause of hemiparetic cerebral palsy (CP). Even with prompt behavioral therapy, ongoing
significant residual motor impairments are common in these children. In this case, innovative
interventions that take advantage of the early critical window for optimizing outcomes are
urgently needed—in infancy. Thus, understanding the early brain reorganization before the
brain has not yet largely reorganized is critical for developing efficacious early
intervention.
Current pediatric studies have employed non-invasive brain stimulation, and most commonly use
the single or paired-pulses of Transcranial Magnetic Stimulation (TMS) to evaluate brain
plasticity by assessing cortical excitability. To date, there is only one infant study using
TMS to assess cortical excitability with perinatal stroke. As a unique aspect of
investigation, this study will combine Magnetic Resonance Imaging (MRI)/ Diffusion Tensor
Imaging (DTI) and TMS to provide an additional opportunity to assess both the cortical
excitability and corticospinal tract (CST) integrity in infants with perinatal stroke.
Identifying the association between laboratory assessment results and developmental outcomes
is also critical. The General Movements Assessment (GMA) is a quick and non-invasive way to
evaluate motor performance and to predict CP in high-risk infants before 20 weeks of age
(corrected age for preterm infants). The BSID-III is a standardized, norm-referenced
developmental assessment validated for use for children 1-42 months of age to assess motor
function. Thus, the purpose of this study is to use MRI/DTI and TMS to comprehensively
examine both the CST integrity and cortical excitability in infants following perinatal
stroke, and to identify association with motor outcome as evaluated by movement assessment
Specific Aims/Study Objectives
Aim 1: Use TMS to index maladaptive cortical reorganization by assessing the relative
excitability of corticospinal projections from each hemisphere to upper extremity musculature
in 3 to 24 month old children who have a confirmed diagnosis of perinatal stroke.
Hypothesis: The ipsilesional hemisphere will have a smaller "map volume" (lower cortical
excitability) than the contralesional hemisphere (larger map volume).
Aim 2: Index maladaptive cortical reorganization by evaluating the organizational integrity
of the CSTs bilaterally via fractional anisotropy (FA), a standardized metric derived from
DTI, in infants with perinatal stroke.
Hypothesis 1: Ipsilesional CST will have a lower value of FA than the contralesional CST.
Hypothesis 2: Smaller cortical excitability volumes will be associated with lower values of
FA.
Aim 3: For infants with perinatal stroke, examine the relationship between movement quality
derived from the movement assessment and cortical excitability and with CST integrity.
Hypothesis: Atypical movement assessment outcome scores will be associated with a lower FA
value and lower ipsilesional CST excitability.
Aim 4: Record any feasibility issues that arise, and monitor for adverse events during TMS
cortical mapping and MRI scanning of infants with perinatal stroke.
Hypothesis 1: TMS and MRI assessments of infants with perinatal stroke are feasible.
Hypothesis 2: No seizure or other serious adverse event related to TMS or MRI/DTI will occur
in this study.
Research Design and Methods
Study design and sample size: This study will be a cross-sectional, two-visit pilot study
with MRI scanning on Visit 1, and TMS and movement assessment testing on the Visit 2. Thirty
term or preterm infants between 3 and 12 months of age corrected for prematurity with the
diagnosis of perinatal stroke will be enrolled.
Subjects Recruitment Plan:
Stage 1: For families who contact the investigators with interest in this study after seeing
the recruitment letter or flyer, initial screening process will be completed. This includes
review of medical records obtained by signatures on an authorization form to list the clinics
to be contacted for medical records.
Stage 2: Once the investigators have determined eligibility for study criteria for the
infant, they will mail the family the consent and HIPAA for review, follow-up with a phone
call to discuss any questions and then schedule a consent meeting to discuss and obtain
signatures. If the family deems appropriate, this can occur on the same day as Visit 1.
Procedures
Visit 1 (MRI/DTI)
Preparatory Activity:
One week prior to Visit 1, the study team will educate caregivers as to how to prepare the
infant for the optimal MRI experience. Caregivers will receive a digital file with a
recording of the MRI operation sound. The caregivers will be asked to play these sounds while
the infant sleeps so they become familiarized with these noises.
Day of Visit:
Infants will be fed, by their caregiver in a separate calming room, and then allowed to fall
asleep for MRI scanning. A memory foam mattress for infants will be used to support them
firmly and comfortably on the scanner table. Both silicone infant ear plugs and ear protector
will both be used to diminish the noises during scanning. One researcher will stay with the
infants throughout the scanning session to ensure and monitor infants' responses and safety.
Subjects will be scanned on a Siemens 3Tesla (magnet strength) system at the Center for
Magnetic Resonance Research (CMRR).
The scan protocol will include both an anatomical T1-weighted structural MPRAGE scan with
spatial resolution 1x1x1mm3 that will be used to guide the TMS testing in Aim 2 and DTI which
will allow investigation of the variation in connectivity of the CST in these infants with
perinatal stroke. High angular resolution diffusion imaging (HARDI) with whole-brain coverage
using the 'Human Connectome Project' (HCP) DTI sequence and spatial resolution
1.8x1.8x1.8mm3, b-value=1500 s/mm2, 128 gradient directions and 15 additional non-diffusion
weighted images will be obtained. HCP tractographic methods will be applied to the HARDI data
to define the two CST's and compute the integrity metrics of track volume and mean fractional
anisotropy (FA). The complete MRI dataset will be obtained in less than 38 minutes.
Visit 2 (Movement Assessment and TMS):
Visit 2 will be scheduled within 7 days after Visit 1 to avoid nonsynchronous results of
MRI/DTI and TMS due to natural developmental changes of central nervous system.
Movement Assessment:
For GMA scoring, infants will be placed in supine position wearing only a diaper to allow for
clear observation of trunk and limbs spontaneous movements. Infants will be observed and
videotaped for 5-10 minutes in an awake but calm state without interacting with people around
them or while playing with a toy. The classifications of "typical" and "atypical" of
different movement categories of GMA will be determined to define the ranks of motor outcomes
in each infant.
The BSID-III motor scales will be administered and scored by a pediatric physical therapist.
This assessment will take approximately 30-45 minutes to complete and involves assessing a
child's natural movements and interactions with toys and objects. The BSID-III is a
norm-referenced assessment that allows comparison of scores to typically developing age
matched peers.
TMS:
Single-pulse TMS (Bistim2, Magstim, UK) with a 50mm figure-of-eight coil (P/N4186-00,Magstim,
UK) will be used to assess cortical excitability from the M1 region of both the ipsilesional
and contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation
system (Brainsight, Rogue Research, Montreal, Quebec, Canada). Each infant's MRI will be
projected onto the neuronavigation system to assist with localization of the motor cortex (T1
MPRage).
Mapping (10 minutes): A 5-by-5 cortical grid of target (25 targets in total) with the
interval 1 cm (4X4 cm2) will be generated over the motor cortex area in the Neuronavigation
System. A response map based on the peak-to-peak amplitude of MEP will be created in real
time by a customized program (LabVIEW, v2012, National Instruments, Austin, TX) program.
Hotspot determination and motor threshold determination (15 minutes): The target with the
greatest motor evoke potential (MEP) peak-to-peak amplitude will be defined as the hotspot
which is the most responsive location on the motor cortex. After determining the hotspot, the
motor threshold (MT) will be assessed over the hotspot. We define the resting MT as the
minimal TMS output necessary to produce MEPs with a peak-to-peak amplitude >50 microvolts in
at least 3 out of 5 consecutive trials. EMG signal will be recorded using surface
electromyography (EMG) electrodes attached over bilateral biceps based. All data will be
collected by a custom EMG amplifier and data acquisition system and stored by LabVIEW program
(National Instruments, Austin, TX) for offline analysis.
Anticipated Risks/Risk Mitigation:
MRI-Dislodging of indwelling metals and disruption of medical devices: Exclude if
metal/medical devices are incompatible.
MRI-Metal projectiles inadvertently presented during MRI: Conduct on-site screen and removal
of potential projectiles (coins, keys, etc).
MRI-Temporary mild hearing loss due to noise level of equipment: Subjects will wear earplugs
(~20 decibel reduction) and headphones (~35 dB reduction) during MRI to protect against
excessive noise MRI-Discomfort due to positioning: Investigator to be present in MRI room
throughout the scan with visual and tactile monitoring MRI-Wake up and move during the MRI
scanning: One investigator will stay with the infants throughout the scanning process to
monitor infants' arousal state and secure the infants if the infants are fully awake
TMS-Stimulation over a tumor which may alter metabolic activity: Screen appropriately for
exclusion criteria of neoplasm.
TMS-Threshold altering pharmacologic agent: Physician review of each medical record for
determination of appropriateness for study inclusion.
TMS-Pain: Age-appropriate Vital signs (HR, RR and BP), skin integrity, distress responses
will be continuously monitored for determination of pausing or stopping.
TMS-Fatigue, Sleepiness: Infant arousal state will be monitored and recorded each minute
during the TMS test TMS-Temporary mild hearing loss due to noise level of equipment: Silicon
infant-appropriate ear plugs will be inserted before TMS and continuously checked for
placement.
TMS-Safe practices will be further ensured by establishing the location for testing within
the University of Minnesota's Clinical and Translational Science Institute (CTSI), where the
equipment and personnel to manage a seizure or other complications are present if an adverse
event occurs, the protocol will be following and the infant will be assessed and the study
reviewed for safety.
TMS-No serious adverse events have been reported from the few published studies investigating
TMS in infants. As the innovation of this study is to investigate comprehensively both the
safety and feasibility of TMS and neuroimaging in infant, we have devised complete individual
and entire study stopping rules.
GMA-Concern for facial recognition and loss of anonymity: The recording will be destroyed
after it is coded, up to 5 years after the completion of the study. This recording will not
be used for any purposes outside of the research study.
Follow up assessments will be repeated at 12 and 24 months of age corrected for prematurity.
The investigators will incorporate a follow-up phone call 1-month after participation to
continue the assessment of safety. Questions pertaining to change in medical status,
including any onset of seizures will be asked.
Inclusion Criteria:
- Birth diagnosis of unilateral perinatal stroke by cranial ultrasound, computer
tomography (CT) or magnetic resonance imaging (MRI)
- Corrected gestational age between 3 and 5 months of age
Exclusion Criteria:
- Metabolic Disorders
- Neoplasm
- Disorders of Cellular Migration and Proliferation
- Acquired Traumatic Brain Injury
- Received surgeries that may constraint current spontaneous movements
- Indwelling metal or incompatible medical devices
- Received surgeries that may constraint current spontaneous movements
- Other neurologic disorders unrelated to stroke
- Small for gestational age (SGA): Infants are smaller in size than normal for the
gestational age
- Apneic episodes and syncope (known heart defects) for the safety of participants in
the stud.
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