跳至主要内容
临床试验/NCT02101398
NCT02101398终止不适用

Etude de l'Effet de Stimulations transcrâniennes en Courant Continu (tDCS) Sur Les Performances en dénomination Chez le Sujet Aphasique à Moins d'un an de Son Accident Vasculaire cérébral : Comparaison de 5 Configurations de Stimulation

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
2
主要终点
Percentage of improvement of picture naming

研究概览

简要总结

The aim of this work is to study the effect of transcranial direct current stimulation combined with naming therapy in acute and post-acute stroke comparing four bihemispheric positioning electrodes to a sham condition.

详细描述

TDCS have shown a positive effect on clinical outcome in naming treatment in aphasic subjects however some aspects as the positioning of the electrodes on the head are still unclear. That is why we compare the effects of four different positionings of the electrodes (two anterior over Broca's area and its homologue and two posterior over Wernicke's area and its homologue) to a sham stimulation in order to observe if a more important effect of one or another positioning could be found.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • man or woman of 18 years and older
  • aphasic patient following a first left hemispheric stroke
  • BDAE 3.0 aphasia score > or = to 1
  • stroke within 3 to 12 months before inclusion in the study
  • mother tongue = French
  • right handedness
  • signed informed consent

排除标准

  • history of other neurologic pathologies
  • epileptic seizure within 2 months before inclusion
  • bilingual patient (2 mother tongues)
  • history of cranial surgery
  • presence of intracerebral metallic material
  • unauthorized molecules at inclusion : sulpiride, rivastigmine, dextromethorphan, carbamazepine, flunarizine, levodopa
  • pregnant, parturient or lactating woman

结局指标

主要结局

Percentage of improvement of picture naming

时间窗: Before stimulation and immediately after stimulation

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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