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临床试验/NCT01539109
NCT01539109已完成不适用

Improving Spinal Cord Injury Rehabilitation Interventions by Retraining the Brain With Stimulation: Applying Concepts From Stroke

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年11月最近更新:
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 Upper Limb Function from Baseline

研究概览

简要总结

The purpose of this study is to investigate whether combining a noninvasive method of brain stimulation, called Transcranial Direct Current Stimulation (tDCS), enhances the effect of training of the affected upper limbs in patients with incomplete Spinal Cord Injury.

详细描述

The long-term objective of this study is to optimize the rehabilitative potential in spinal cord injury (SCI) by maximally harnessing the potential available for functional neural plasticity. SCI is an important cause of serious, long-term disability in young adults. This fact, further complicated by rising disability-related costs, makes SCI a significant economic and social burden. Upper limb dysfunction is one of the most prevalent and debilitating impairments. More than 75% of patients with quadriplegia (paralysis of all 4 limbs following spinal cord injury in neck and upper back) prioritize return of upper limb function over any other lost function. Alleviating deficits of the upper limb may represent a cost-effective stategy to reducing the burden of SCI.

Although various exercise programs and neuromuscular stimulation methods have been employed to mitigate functional impairments of the arm and hand, success of these modalities is still debated. Evidence for efficacy of rehabilitation is inconclusive as outcomes are variable, confounded by methodological issues, and have shown poor generalizability. It is now speculated that limited succcess of rehabilitation emerges from inability of current methods to adequately harness the potential for significant neuroplasticity available in SCI.

Even though the site of damage in SCI does not involve the brain, the neural networks in the brain that control movement of the arm and hand are markedly affected. These regions lose their territory that the investigators argue could hamper effects of upper limb therapy. The Investigators objective is to directly modulate adaptive plasticity in these regions of the brain to enhance function of the upper limb in iSCI. The Investigators central hypothesis is that noninvasive brain stimulation, called transcranial direct current stimulation (tDCS), when delivered concurrently with rehabilitation will generate synergistic functional advantage. Adaptive plasticty would be obeserved as changes in structure of pathways emerging from the brain and the individual's function.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with incomplete spinal cord injury (iSCI) that occurred at least 6 months ago

排除标准

  • History of epilepsy in a first degree relative
  • Use of anticonvulsants
  • Implanted pumps, shunts, or neurostimulators
  • Neurologic condition affecting sensorimotor systems
  • Brain tumor
  • Substance abuse
  • Damaged skin on the scalp
  • Concurrent upper limb rehabilitation

结局指标

主要结局

Change in Upper Limb Function from Baseline

时间窗: Strength, activities and impairments will be measured at The patient will receive TMS during at baseline, post-2 weeks, post-4 weeks and 3-month followup

Upper limb function will be measured by the Upper Extremity Motor Score (UEMS), capacity tasks in the form of the Grasp and Release Task (GRT) test, and pinch grip impariment that will be measured by a maximum voluntary isometric pinch force.

次要结局

  • Magnetic Resonance Imaging (MRI) of the brain(The patient will receive MRI during at baseline, post-2 weeks, and post-4 weeks)
  • Physiology of Brain studied with Noninvasive Brain Stimulation using Transcranial Magnetic Stimulation (TMS)(The patient will receive TMS during at baseline, post-2 weeks, and post-4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ela B. Plow

Project Scientist

The Cleveland Clinic

研究点 (2)

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