Transcranial Magnetic Stimulation in Children With Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Tolerance to repetitive stimulation
研究概览
简要总结
This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke.
详细描述
The investigators will begin to test the hypothesis that rTMS will be tolerated and will result in improved hand strength and mobility when compared with sham stimulation.
Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have chronic motor sequelae from a stroke.
Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy hemisphere improves grip strength and hand mobility when compared with sham stimulation in controls.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •A history of ischemic or hemorrhagic stroke at least 6 months prior to recruitment, and causing current unilateral motor impairment of hand function (scoring 1-3 on a modified Ashworth scale; scale explained in Appendix).
- •Cerebral infarction spares the transcallosal pathways.
- •Cerebral injury confirmed by brain MRI or CT
- •Ages 6-18 years inclusive.
排除标准
- •The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus.
- •Infarction of the cortical motor areas.
- •Presence of a brain tumor or suspected neurodegenerative disease.
- •Intractable epilepsy or a history of poorly controlled epilepsy.
- •Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines)
- •Hand function limited to rigid flexion or extension (score = 4 on the modified Ashworth scale)
- •Disorders causing hallucinations, delusions, or excessive anxiety or depression.
- •Pre-existing chronic pain syndromes including intractable headache and chronic daily headache.
- •Any sensorimotor or cognitive impairment that prevents valid responses on study measures.
- •Bilateral strokes (cerebral injuries) involving motor cortex and/or corpus callosum
- •All patients and parents must be naïve regarding the effects and sensations of rTMS (i.e., patients and/or parents with prior exposure to TMS will be excluded).
- •Subject has had a recent neurosurgical procedure involving the brain.
- •Subject suffered traumatic brain injury that places the subject at risk of seizures.
结局指标
主要结局
Tolerance to repetitive stimulation
时间窗: Up to 2 days
The patient's reports of side effects recorded on the CRF at each session will be tabulated and the pre-stimulation scores will be subtracted from the post-stimulation scores. Cognitive function will be assessed with 6 measures (Executive Function / Spatial Problem Solving, Psychomotor Function / Speed of Processing, Visual Attention / Vigilance, Visual Learning \& Memory, Verbal Learning \& Memory, and Attention / Working Memory measures). As with the tolerance assessments, we will tabulate before-stimulation and after-stimulation assessments and analyze the difference.
次要结局
- Upper extremity strength and mobility(Up to 2 Months)
研究者
Warren Lo
Associate Clinical Professor of Pediatrics and Neurology
Nationwide Children's Hospital