Stroke Clinical Trial
Official title:
Modulation of Brain Plasticity After Perinatal Stroke: The PLASTIC CHAMPS Trial
Newborn stroke is the leading cause of a common type of cerebral palsy (CP) that affects
thousands of Canadian children and families. Treatments for CP are generally ineffective, and
have traditionally focused on the weak body rather than the injured brain. Understanding how
the newborn brain responds to injuries like stroke (plasticity) carries the greatest
potential for better treatments. We propose to study the ability of two interventions to
modulate brain plasticity toward better function in children with stroke-induced CP. One is a
rehabilitation method called constraint-induced movement therapy (CIMT), the other is a type
of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is safe
and comfortable for children and we recently showed it could improve motor function in
children with stroke.
We will perform a special study to test both treatments simultaneously. Children 7-18 years
with stroke-induced CP will be recruited into the study from across Alberta. Each child will
randomly receive either TMS, CIMT, both, or neither each day for two weeks while attending
our new HemiKids Power Camp for motor learning. Improvements will be measured by trained
therapists over 1 year. TMS will also measure brain plasticity, both initially and following
treatment. Our lead investigator is an expert in both newborn stroke and TMS and has
assembled an experienced team of accomplished collaborators to ensure the completion of this
important work. This will be the largest study of children with CP examined in this manner.
This will be the first clinical trial of non-invasive brain stimulation (TMS) in CP, the
largest trial of CIMT (and the first exclusive to newborn stroke), and the first study
allowing the direct comparison of two different therapies. In establishing the first
dedicated pediatric TMS laboratory in Canada, we will be the first to measure plasticity
changes in newborn stroke, advancing new treatments of this previously untreatable and
disabling disease.
Patient recruitment is currently underway at Alberta Children's Hospital. Application is
currently underway to expand recruitment to Northern Alberta through the Glenrose
Rehabilitation Hospital and Stollery Children's Hospital, to enable patients from Northern
Alberta greater opportunity to participate as subjects in this study.
Perinatal stroke is the leading cause of the most common term-born cerebral palsy: hemiplegic
CP (HCP). With morbidity spanning all aspects of a child's life and lasting for decades,
global impact is large. Mechanisms are poorly understood and prevention strategies remain
elusive. Treatments are limited, leading to loss of hope in children and families that merits
exploration of new interventions. Constraint-induced movement therapy (CIMT) may benefit but
proper clinical trials are required. The investigators clinical-radiographic classifications
have established perinatal stroke syndromes correlating with neurological outcome. Most
common are: (1) arterial ischemic stroke of the middle cerebral artery (AIS-MCA) featuring
cortical and subcortical damage acquired at birth and (2) periventricular venous infarction
(PVI), a novel subcortical injury acquired in utero. These syndromes differ in the essential
variables for plastic organization after perinatal injury: location and timing. In addition,
recent animal and human studies suggest they may share a similar maladaptive plasticity
whereby motor control of the weak side is "installed" in the non-lesioned hemisphere during
development. Despite the ideal plasticity model such focal injury in a young brain provides,
studies have been limited and suffer from small numbers of older patients with heterogeneous
lesions. The value of studying plastic organization will be realized upon translation into
meaningful patient benefits.
Transcranial magnetic stimulation (TMS) offers non-invasive measurement of the
neurophysiological brain properties underlying neuroplasticity. Repetitive TMS (rTMS) may
modulate such systems with therapeutic effect. the investigators recently demonstrated the
ability of rTMS to improve motor function in children with chronic stroke. Advances in
perinatal brain injury and neurodevelopment are, for the first time, affording novel windows
of opportunity for interventions to direct plastic organization toward better outcomes. Via
the Alberta Perinatal Stroke Project (APSP), the investigators propose a clinical trial of
two interventions to improve function in HCP while measuring the fundamental
neurophysiological properties at play.
Aim 1. Determine if rTMS and CIMT can improve motor function in HCP. Hypothesis: Two weeks of
daily rTMS improves motor function at 30 days.
Aim 2. Define the neurophysiology of motor organization in strokeāinduced HCP at baseline and
following rTMS and CIMT.
Hypothesis: rTMS and CIMT reduce excitability of the non-lesioned motor cortex.
Population-based studies through the Alberta Perinatal Stroke Project (APSP) are establishing
the largest perinatal stroke cohort to date. The investigators will complete a factorial 2 x
2 randomized clinical trial to determine the ability of daily rTMS and CIMT to improve motor
function in children with HCP. Families will attend a child-centered, custom-designed
intensive motor learning rehabilitation program (KidsCan Power Camp) for 2 weeks. Outcomes
include validated measures of motor function and CP quality of life. The investigators will
simultaneously measure the neurophysiology of plastic organization using TMS including
cortical excitability, interhemispheric inhibition, and short interval intracortical
inhibition. Baseline measures will define organization patterns while post-interventional
measurement will evaluate the neurophysiological effects of rTMS and CIMT. Four groups of 16
children each (n=64) will be studied over 24 months with interim safety analysis after 10 and
32 patients.
Successful completion is assured by principle investigator experience in perinatal stroke and
TMS and the collaborative support of world leaders in pediatric and adult stroke, TMS, basic
neuroscience, and physiatry/rehabilitation. Understanding perinatal stroke plasticity and
discovering methods to modulate it toward better outcomes carries a large impact, greatest
for children with CP and their families.
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