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临床试验/NCT04021160
NCT04021160已完成不适用

The Efficacy of Navigated Perilesional Repetitive Transcranial Magnetic Stimulation on Post-Stroke Visual Field Defects

Ain Shams University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年6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
32
试验地点
2
主要终点
Change in Mean Deviation (MD) of Automated Perimetry

研究概览

简要总结

Visual field defects (VFD) usually do not show improvement beyond 12 weeks from onset. Plasticity occurs in areas of residual vision (ARV) at the visual field which are the functional counterpart of partially damaged brain regions at the areas around brain lesion. Few treatment options are currently available for post-stroke VFD. In this pilot study, the effect of repetitive transcranial magnetic stimulation (rTMS) applied to these areas on VFD in patients with cortical infarction will be studied. Patients will be divided into two groups; an active group which will receive active stimulation and a sham group which will receive placebo stimulation through a sham coil.

详细描述

Visual functions are widely distributed over large areas within the cerebrum. Secondary to such wide distribution, visual field defects (VFD) are a common outcome of brain insults especially cerebrovascular stroke whether hemorrhagic or ischemic. Among these, homonymous hemianopia is the most frequently encountered VFD in clinical practice. VFD ranges from 8.3% to 16% in the chronic stage of stroke, while it reaches 25% in acute and subacute stages of stroke. In other studies, it was reported to be even higher. In a database of 11900 stoke patients, VFD was found in 60.5% with homonymous hemianopia accounting for 35%.

These VFDs usually show some degree of improvement within few months from onset secondary to resolution of edema and diaschisis, yet by 3 to 6 months the condition tends to become stationary with no further improvement and only 5% of patients will show full recovery of their visual field. In some studies recovery was mostly along the first 10 days of insult followed by decrease in recovery rate that nearly stops 10-12 weeks after insult. Beyond this time point, very few cases develop spontaneous recovery.

Plasticity occurs in areas of residual vision (ARV) at the visual field borders rather than areas of absolute blindness. These ARVs are the functional counterpart of partially damaged brain regions at the perilesional areas. Recovery of function - both early in life and in adults - is stimulation dependent. This stimulation can be either through visual experience, behavioral training or brain stimulation. To the investigator's knowledge, direct current stimulation (DCS) is the only brain stimulation modality that has been studied in cases of VFDs. Results showed that DCS can expand visual field in stroke patients with the effects being stable over time.

In the current study, it is hypothesized that stimulation of the perilesional seemingly healthy brain tissue close to the visual cortex would result in clinical improvement based on the concept of ARVs. To achieve this precise targeting, navigated rTMS would be the most suitable technique.

The investigators aim to study the effect of navigated repetitive transcranial magnetic stimulation (rTMS) applied to perilesional areas on patients with cortical visual field defects (cVFD) due to stroke.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a brain imaging showing vascular lesion involving visual cortical area
  • Duration of at least 3 months.

排除标准

  • Visual field defects of ophthalmologic origin
  • Causes of severe visual impairment other than visual field defects
  • Drug abuse
  • Past history or family history of epilepsy
  • Skull bone defects
  • Implanted metallic devices

结局指标

主要结局

Change in Mean Deviation (MD) of Automated Perimetry

时间窗: 6 weeks

Change in mean deviation (MD) from baseline will be assessed using automated perimetry's full threshold 30-2 visual field test.

次要结局

  • National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)(6 weeks)
  • Change in Visual Field Index (VFI) of Automated Perimetry(6 weeks)

研究者

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

Nevine El Nahas

Professor

Ain Shams University

研究点 (2)

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