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NonInvasive Brain Stimulation in Stroke Patients (RTNIBS)

2015年3月27日 更新者:NHS Greater Glasgow and Clyde

A Randomised Trial of Non-Invasive Brain Stimulation (NIBS) in Stroke Survivors

After a stroke affecting the right side of the brain, many patients are affected by "spatial neglect": the damage to the brain causes them to ignore the left side of their surroundings. At its most extreme they may be unaware that they have a left side, or believe that it is moving normally when it is in fact paralysed. In milder cases, people may be unable to recognise touch on the left side if their right side is also being touched, or objects in their left visual field if something is visible to their right. Neglect alters peoples' quality of life profoundly, often renders them more dependent on others to undertake basic activities of daily living, and makes effective rehabilitation much more difficult.

The limited success of current treatment approaches indicates gaps in understanding of the underlying mechanisms of neglect and its recovery. Recent data suggest that the problems in responding to the left side are a result of an imbalance of activity in those parts of the brain responsible for deciding which side to pay attention to. It might therefore be possible to help people with neglect by "rebalancing" the brain either by increasing activity in the damaged side, or alternatively by reducing activity in the undamaged side. In this pilot study, the investigators will test whether they can help by doing the second of these things.

The investigators propose to conduct a pilot clinical trial to explore whether using electric currents to temporarily modify the activity of specific areas of the intact side of the brain, influences recovery from neglect, when used either alone, or in combination with a training method that has previously appeared promising as a treatment. Brain activity will be modified using a technique called "transcranial direct current stimulation (tDCS)", in which small electric currents are applied to the scalp with a wire covered in damp cotton pads. This will be done over the specific parts of the brain that are responsible for focusing attention to one side.

The investigators will compare the clinical outcomes of four interventions (1: behavioural, 2: tDCS, 3: a combination of both and 4: control).

The investigators hope that these studies will advance their understanding of what treatments may help people with neglect, and how they might work.

研究概览

研究类型

介入性

注册 (预期的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Ischemic stroke affecting the right hemisphere, confirmed by CT or MRI.
  2. Persistent neglect for one month after ictus (confirmed by BIT).
  3. Prestroke functional independence (modified Rankin Scale score 0-2).
  4. Between 18-90 years of age

Exclusion Criteria:

  1. Patients younger than 18.
  2. Patients who do not understand verbal or written English (ie.need of translaters)
  3. bilateral infarcts (Confirmed by CT, MRI)
  4. Dementia (MOCA, Score <26).
  5. Neurological Disease (eg. Parkinson's Disease, epilepsy, MS)
  6. Significant morbidity (eg cancer, severe cardiac failure) likely to affect participation.
  7. Alcohol excess (more than 50/40 units a week for men/women respectively).
  8. Patients who fall under the exclusion criteria for TDCS which includes patients suffering from a stroke related seizure :

History of epilepsy, medications or psychoactive drugs that can lower seizure threshold [imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel dust), ketamine, gammahydroxybutyrate (GHB), alcohol, theophylline]. Withdrawal from alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate. Patients who are pregnant or have suffered from a stroke-related seizure.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Action Training
Training exercise which involves patients lifting up rods of different sizes and shifting their grip if this is too far to one side
实验性的:tDCS
A constant 1mA current will be applied to the left (undamaged) side of the scalp with an electrode covered with a damp cotton pad (25 cm2). The current will be applied for 15 minutes per day, with a total of 10 sessions over 3 weeks.
其他名称:
  • 时间点DCS
实验性的:Action Training + tDCs
This will involve the same procedure as in action training only but with tDCS applied for 15 minutes during the rodlifting.
其他名称:
  • 时间点DCS
安慰剂比较:Control training
For the control training, patients will be asked to simply reach for the right hand side of each rod with their right (unaffected) hand and lift it

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in Behavioural Inattention Test (BIT)
大体时间:6 months post intervention
6 months post intervention

次要结果测量

结果测量
大体时间
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
大体时间:baseline
baseline
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
大体时间:3 weeks
3 weeks
Compliance as measured by adherence to task instructions (percentage of intervention sessions, BIT tests completed)
大体时间:6 months
6 months
Retention Numbers
大体时间:baseline
baseline
Retention Numbers
大体时间:3 weeks
3 weeks
Retention Numbers
大体时间:6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年3月1日

初级完成 (预期的)

2018年6月1日

研究完成 (预期的)

2018年6月1日

研究注册日期

首次提交

2015年3月10日

首先提交符合 QC 标准的

2015年3月27日

首次发布 (估计)

2015年3月30日

研究记录更新

最后更新发布 (估计)

2015年3月30日

上次提交的符合 QC 标准的更新

2015年3月27日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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