Perinatal Stroke: Understanding Brain Reorganization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02743728|
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : April 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Device: Magnetic Resonance Imaging Device: Transcranial Magnetic Stimulation Behavioral: General Movement Assessment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Perinatal Stroke: Understanding Brain Reorganization Through Infant Neuroimaging and Neuromodulation|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: All Infants
Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed.
Device: Magnetic Resonance Imaging
Anatomical and Diffusion Tensor Imaging Analysis.
Device: Transcranial Magnetic Stimulation
Assessment of brain (cortical) excitability
Behavioral: General Movement Assessment
Spontaneous movement assessment of infant while lying in unperturbed state.
- Cortical excitability (map volume) of ipsilesional and contralesional hemispheres assessed by transcranial magnetic stimulation (TMS) in infants with perinatal stroke [ Time Frame: Day 2, 2 hour assessment performed once in the entire study ]TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimate time of TMS assessment is around 2 hours during Visit 2.
- Bilateral corticospinal tract integrity (fractional anisotropy) derived from diffusion tensor imaging [ Time Frame: Day 1, 2 hour Imaging Session performed once in the entire study ]Magnetic resonance imaging (MRI)/diffusion tensor imaging (DTI) will be performed when infants are sleeping with a real scanning time of 38 minutes during visit 1.
- The association of movement quality (atypical vs. typical movement) with ipsilesional cortical excitability and relative tract integrity between hemispheres (ratio of FA values) [ Time Frame: Day 2, 15 minute assessment performed once in the entire study ]The movement quality will be assessed by general movement assessment (GMA). GMA requires 5-10 minutes video taping when infants are placed in spine position for scoring.
- Recording adverse events during TMS cortical mapping and MRI scanning of infants with perinatal stroke [ Time Frame: Day 1 during 2 hour session, and Day 2 during 2 hour 15 minute sessions once during the entire study ]Assessment of vital signs changes and pain/stress responses during both MRI and TMS assessment during visit 1 and visit 2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743728
|Contact: Maureen E Boxrud, BAemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Maureen E Boxrud, BA 612-626-6415 firstname.lastname@example.org|
|Principal Investigator:||Bernadette T Gillick, PhD, MSPT, PT||University of Minnesota - Clinical and Translational Science Institute|