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临床试验/NCT03635775
NCT03635775已完成不适用

Effects of Single-session Transcranial Direct Current Stimulation in Children With Cerebral Palsy

University of Minnesota2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Motor Evoked Potential Amplitude

研究概览

简要总结

The goal of this study is to characterize individual responses to a single application of transcranial direct current stimulation (tDCS) in children with unilateral cerebral palsy (UCP), and to test which electrode configuration produces changes in brain excitability and motor function. Participants with UCP, ages 7-21 years, will be assigned to one of four tDCS groups. Using single-pulse transcranial magnetic stimulation, the investigators will assess cortical excitability before and at regular intervals up to 1 hour following tDCS. The knowledge gained from this study will advance the field through more targeted approaches of neuromodulatory techniques in this population and others, using individual characteristics to guide optimal treatment

详细描述

Hemiparesis, or weakness on one side of the body, is common following stroke early in life. The broader clinical diagnosis for this type of childhood movement impairment is unilateral cerebral palsy (UCP). Cerebral palsy effects about 3 out of every 1000 live births in the Unites States, and produces lifelong motor, sensory, and cognitive disability.

Neurorehabilitation has primarily focused on intensive motor training to encourage use of the affected extremities in an effort to produce use-dependent neuroplasticity in the brain. Such interventions are effective, but require a burdensome amount of time, 60-90 hours per week, for both the child and therapist. Furthermore, some children do not respond at all to such training.

Neuromodulation is a relatively new field that aims to influence the brain's neuronal activity through direct application of magnetic (TMS) or electric (tDCS) energy. It is thought the combination of neuromodulation and motor training may reduce the dosage of training needed, and would promote recovery to a greater extent for more individuals. Indeed, previous work in adult stroke demonstrate a benefit of combining repetitive TMS (rTMS) and tDCS with motor training, compared to training alone. These types of synergistic interventions are just beginning to be used in children with UCP, with some preliminary data showing potential benefit.

One of the many questions surrounding neuromodulatory interventions like tDCS is how to reliably predict changes in neuronal activity. The currently hypothesized effects of tDCS are polarity-specific: anodal tDCS depolarizes membranes resulting in increased in neuronal excitability; cathodal tDCS hyperpolarizes tDCS resulting in decreased neuronal excitability. Furthermore, these effects scale with the intensity of stimulation: the larger the direct current delivered, the greater the change in excitability. This framework has been used to guide almost all studies using tDCS to produce a change in brain function and resulting behavior.

More recently, the field is beginning to appreciate that this framework may be overly simplistic. For example, when a cognitive task is performed concurrently with tDCS, there are reported non-linear effects related to current intensity and direction of change in excitability. Such work has a significant impact on the use of tDCS in rehabilitation, which advocates for the pairing of stimulation with on-going activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and families will be masked to intervention group. The research team members performing assessments will be masked to intervention group.

入排标准

年龄范围
7 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Motor Evoked Potential Amplitude

时间窗: approximately 5 minutes

Motor evoked potential is a measure of cortical excitability using transcranial magnetic stimulation. MEP is measured as the amplitude of electrical activity from finger muscles. Outcome is reported as the percent change in MEP amplitude from pre-intervention to immediately post-intervention.

次要结局

  • Change in Movement Accuracy(Approximately 1 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Single-session tDCS in Cerebral Palsy | 临床试验