跳至主要内容
临床试验/NCT00271388
NCT00271388已完成不适用

Noise Enhanced Galvanic Vestibular Stimulation in Hemispatial Neglect

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2006年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
2
主要终点
Measures of Hemispatial Neglect

研究概览

简要总结

The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones.

详细描述

The purpose of the current proposal is to pilot a new and potentially improved treatment for neglect. The procedure involves the delivery of transcutaneous small-amplitude current to the vestibular nerves that lie directly below the mastoid bones. With the intention of boosting activity in the damaged left hemisphere, positive and negative current is delivered to the left and right mastoids respectively. While successfully used to rehabilitate gait and balance disorders, the procedure has only once been applied to neglect.

In the present investigation, we will first confirm and then optimize the conditions under which galvanic vestibular stimulation (GVS) ameliorates neglect. This in turn will justify subsequent work (in a later funding cycle) that will demonstrate the safety and efficacy of the treatment on a much larger clinical scale, and merit the construction of a miniaturized portable device.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants must be literate in English
  • Right handed
  • Have corrected near-visual acuity of 20/40 or better
  • Patients must also have a minimum of twelve years education
  • These inclusionary criteria are based on the data of both Black, Yu, Martin, and Szalai (90) and our own studies.
  • They are intended to assure that only patients with sufficiently severe symptoms will be admitted to our study.

排除标准

  • Exclusionary criteria include:
  • Homonymous hemianopia
  • Presence of a severe field cut extending toward the midline on formal perimetry (however many patients who have field cuts restricted to the periphery will be able to fully perceive our stimulus displays so can be included
  • Evidence of aphasia on clinical examination (crossed aphasia)
  • A significant history of other neurological or psychiatric illness or drug/alcohol abuse

研究组 & 干预措施

Parameter Determination

Experimental

Testing potential effects of GVS on the symptoms of neglect

干预措施: Transcutaneous current to the vestibular nerve (Device)

结局指标

主要结局

Measures of Hemispatial Neglect

时间窗: 30 days

Improvement of Hemispatial neglect

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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