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临床试验/NCT02935413
NCT02935413已完成1 期

Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study

University of Magdeburg4 个研究点 分布在 2 个国家目标入组 14 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
14
试验地点
4
主要终点
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention

研究概览

简要总结

The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.

详细描述

Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.

Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Posterior Cerebral Artery Stroke
  • Visual Field Defect
  • Lesion age 4 weeks up to 6 month max

排除标准

  • Electrical Implants
  • Metal artefacts in head
  • Visual Neglect

结局指标

主要结局

Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention

时间窗: 14-20 days post treatment,

次要结局

未报告次要终点

研究者

发起方
University of Magdeburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernhard A. Sabel

Professor

University of Magdeburg

研究点 (4)

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