Stimulation for Perinatal Stroke Optimizing Recovery Trajectories
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Change from baseline in Assisting Hand Assessment (AHA) at 1 week, 2 month and 6 month post intervention.
研究概览
简要总结
Perinatal stroke causes lifelong neurological disability and most hemiparetic cerebral palsy (CP). With morbidity spanning diverse aspects of a child's life and lasting for decades, global impact is large, including 10000 Canadian children. With pathophysiology poorly understood and prevention strategies non-existent, the burden of hemiparetic CP will persist. Limited treatments lead to loss of hope for children and families, necessitating exploration of new therapies. The investigators have evidence that the investigators have a durable new treatment for perinatal stroke, combining non-invasive neurostimulation and child-centred intensive rehabilitation. Via the CHILD-BRIGHT SPOR national network, the investigators will execute a multicentre trial to prove this treatment can improve function in children with perinatal stroke and hemiparetic CP. Using novel advanced technologies not available elsewhere in the world, the investigators will explore how developmental plasticity determines function and response to neuromodulation therapy. This patient oriented effort will advance personalized, precision medicine in pediatric neurorehabilitation to improve outcomes for disabled children and their families.
详细描述
Aim 1: Establish the ability of tDCS to enhance motor function in children with perinatal stroke.
Hypothesis: Addition of tDCS to intensive motor learning therapy in children with perinatal stroke and hemiparesis will increase the probability of achieving clinically significant gains in function.
Aim 2: Understand the developmental motor neurophysiology of perinatal stroke and the changes that occur during intensive motor learning and the effects of tDCS.
Hypothesis: Therapy-induced functional improvements are associated with increased motor control in the lesioned (stroke) hemisphere as measured by: (a) enlargement of lesioned hemisphere motor maps (robotic TMS), (b) increased functional connectivity between lesioned motor and sensory cortices (rsfMRI), (c) strengthened correlations between lesioned motor cortex NAA and clinical function (MRS), and (d) improved position sense of the affected upper extremity (KINARM robot)
Methods This is a multicentre, randomized, sham-controlled, double blind, phase III clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Clinical and MRI confirmed perinatal ischemic stroke (NAIS, APPIS, PVI)
- •Symptomatic hemiparetic CP including parent/child perceived limitations in function
- •Able to briefly lift light object off a surface (estimated House class 3-6).
- •Informed child consent/assent and parental/guardian consent
排除标准
- •Other neurological disorder not related to perinatal stroke
- •Multifocal stroke
- •Severe hemiparesis (no voluntary contraction, MACS V)
- •Sever spasticity (Modified Ashworth Scale >3)
- •Severe delay or inability to comply with protocol
- •Unstable epilepsy
- •TMS or MRI contraindication
- •Orthopedic surgery, constraint, brain stimulation or other modulatory therapy in past 6 months prior to camp day 1
- •Botulinum toxin injections in past 4 months prior to camp day 1
结局指标
主要结局
Change from baseline in Assisting Hand Assessment (AHA) at 1 week, 2 month and 6 month post intervention.
时间窗: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention
This is the established standard for the objective quantification of bilateral hand function in children with hemiparetic CP141. This Rasch-built evaluation carries the strongest evidence of inter-rater, intra-rater, and test-retest reliabilities, test-validity, and responsiveness to change for bimanual tasks in hemiparetic CP children 8 within our age range. Sensitivity to change and excellent clinimetric properties have been established in multiple pediatric hemiparetic CP clinical trials. Our trained therapists have successfully executed \>100 AHA measurements in our current trial124 with no limitations and robust data.
Change from baseline in Canadian Occupational Performance Measure (COPM) at 1 week, 2 month and 6 month post intervention.
时间窗: 1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention
Individualized, family-centered tool identifying child and family-perceived difficulties in self-care, productivity (school), and activities142. Such subjective measures are essential in hemiparetic CP trials. Validated for our ages and such trials, the COPM was a robust measure in our previous perinatal stroke trials (Figure 4). We have recently characterized how COPM goals are set in this population and their relationship to success (Haspels et al, unpublished).
次要结局
- Change from baseline in Mirror Movements at 1 week, 2 month and 6 month post intervention.(1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention)
- Change from baseline in Children's Hand-use Experience Questionnaire (CHEQ) at 1 week, 2 month, and 6 month post intervention.(1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention)
- Change from baseline in Jebsen Taylor Test of Hand Function (JTTHF) at 1 week, 2 month and 6 month post intervention.(1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention)
- Change from baseline using the Box and blocks at 1 week, 2 month and 6 month post intervention.(1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention)
- Change from baseline in the Quality of Life (QoL) assessment at 1 week, 2 month and 6 month post intervention.(1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 2 months post intervention. 4. 6 months post intervention)
- Change from baseline in mean movements during regular daily activities measured by MotionWatch at 1 week, 2 month and 6 month post intervention.(48 hour ephochs at baseline, 1 week post, 2 months and 6 months post intervention.)
- Change in CNS Vitals battery at 1 week, 2 month and 6 month post intervention(1.Baseline, within one month prior to the start of intervention. 2. 1 week post intervention. 3. 6 months post intervention)
研究者
Adam Kirton
Professor
University of Calgary