Modulation of Brain Plasticity After Perinatal Stroke: The PLASTIC CHAMPS Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Canadian Occupational Performance Measure (COPM).
研究概览
简要总结
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.
详细描述
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 stroke-induced HCP at baseline and following rTMS and CIMT.
Hypothesis: rTMS and CIMT reduce excitability of the non-lesioned motor cortex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Canadian Occupational Performance Measure (COPM).
时间窗: Completed 2 weeks or less before treatment day 1
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
Canadian Occupational Performance Measure (COPM)
时间窗: Completed 6 months after treatment day 10
The COPM is an individualized, family-centered tool designed to guide participants to identify self-perception of difficulties in self-care, productivity (i.e school) and leisure activities.
次要结局
- TMS Tolerability Measure(Completed 6 months after treatment day 10)
- PedsQL Cerebral Palsy Module version 3.0 Young child report (ages 5-7), Child report (ages 8-12), Teen report (ages 8-12)(Completed 6 months after treatment day 10)
- Pediatric Stroke Outcome Measure Short Neuro Exam Child Version (>2 years)(PSOM)(Completed before treatment day 1)
- PedsQL Cerebral Palsy Module version 3.0 Parent Report for young child(ages 5-7), Parent Report for Child(ages 8-12), Parent report for teen(ages 8-12)(Completed 6 months after treatment day 10)
- SHUEE (Shriners Hospital Upper Extremity Evaluation)(Completed 6 months after treatment day 10)
- Box and Blocks Test(Completed 6 months after treatment day 10)
- Grip and Pinch Strength Measures (GS, PS)(Comopleted 6 months after treatment day 10)
- Assisting Hand Assessment (AHA)(Completed 6 months after treatment day 10)
- Melbourne Assessment of Unilateral Upper Limb Function (MAUULF)(Completed 6 months after treatment day 10)
- ABILHAND-Kids -Manual ability measure(Completed 6 months after treatment day 10)
- The Revised Pediatric Motor Activity Log and the Tween Motor Activity Log (PMAL / TMAL)(Completed 6 months after treatment day 10)
- Biometrics Data Sheet(Completed each day during the 10 day camp program)
- Paediatric Stroke Outcome Measure Short Neuro Exam (PSOM-SNE)-Child Version (Children Aged 2yrs and Older)(Completed before treatment day 1)
- Home Program Log(Reassessed 6 months after treatment day 10)
- Camp Evaluation Form(Completed by participants on Day 10 of treatment)
研究者
Adam Kirton
Pediatric Neurologist
University of Calgary