Clinical Trial: Perinatal Stroke: Understanding Brain Reorganization

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Perinatal Stroke: Understanding Brain Reorganization Through Infant Neuroimaging and Neuromodulation

Brief Summary:

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 3-5 months old infants with unilateral 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 exa

Detailed Summary:

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). 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 GMA.

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.