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临床试验/NCT00853866
NCT00853866已完成4 期

Entwicklung Neuronaler Repräsentationen Nach Schlaganfall: Verbesserung Motorischer Leistungen Durch Transkranielle Gleichstromstimulation Und Noradrenerge Co-Stimulation

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
12
试验地点
1
主要终点
JTT

研究概览

简要总结

The hypothesis of the study is that combination of reboxetine/tDCS is more effective in enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to reboxetine and tDCS alone. The protocol is designed as a within-subject, block randomized placebo-controlled double-blind crossover study.

详细描述

One important feature of the human brain is the ability to undergo plastic changes and reorganization after learning and lesions of the nervous system. This ability is of major importance for the treatment of functional deficits after stroke. Stroke is the major disease leading to persistent functional disabilities in Germany. However, the success rate of therapeutic interventions, especially in chronic stroke patients, is still unsatisfactory. Thus, basic science is essential to discover new therapeutic options that bear the potential for translation into clinical practice. Recent evidence is pointing to modulating the motor cortical excitability in order to enhance motor function in stroke patients. For this purpose, reboxetine as a selective reuptake inhibitor of noradrenaline and transcranial direct current stimulation have proven effective in enhancing motor functions needed for daily life activities by 10-12%. These improvements were significant compared to placebo, but still clinically unsatisfactory. Thus, this protocol aims at enhancing the excitability modulatory effect of each single intervention through the combination of reboxetine and tDCS. The hypothesis of the study is that combination of reboxetine/tDCS is more effective in enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to reboxetine and tDCS alone.

The protocol is designed as a within-subject, block randomized placebo-controlled double-blind crossover study. 12 chronic stroke patients with persistent functional deficits of the arm and/or hand will be included. The primary outcome measure is the time needed to fulfill all subtests of the Jebsen Taylor test. All patients undergo four different conditions in four different sessions: 1) reboxetine + verum tDCS; 2) reboxetine + sham tDCS 3) placebo drug + verum tDCS 4) placebo drug + sham tDCS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 86
  • patient is contractually capable
  • first-ever, ischemic stroke
  • minimum time since stroke 9 months
  • a paresis of the arm/hand muscles above 3 on the MRC scale

排除标准

  • multiple cerebral lesions and associated residual deficits
  • severe head trauma in the past
  • ferromagnetic implants in the head/neck region
  • pacemaker
  • a psychiatric disorder or neurological disease besides stroke
  • intake of illegal drugs
  • severe aphasia or cognitive deficits that impede contractual capability
  • contraindications for reboxetine (seizures, glaucoma, prostate hyperplasia with urinary retention, cardiac arrhythmias, potential interactions with co-medication)
  • pregnancy
  • breast-feeding patients

研究组 & 干预措施

RBX + tDCS

Experimental

reboxetine + tDCS verum

干预措施: reboxetine (Drug)

RBX + tDCS

Experimental

reboxetine + tDCS verum

干预措施: tDCS verum (Device)

RBX + sham stimulation

Active Comparator

reboxetine + sham tDCS

干预措施: reboxetine (Drug)

RBX + sham stimulation

Active Comparator

reboxetine + sham tDCS

干预措施: tDCS sham (Device)

PLC + tDCS

Active Comparator

placebo drug + verum tDCS

干预措施: Placebo (Drug)

PLC + tDCS

Active Comparator

placebo drug + verum tDCS

干预措施: tDCS verum (Device)

PLC + sham stimulation

Sham Comparator

placebo drug + sham tDCS

干预措施: Placebo (Drug)

PLC + sham stimulation

Sham Comparator

placebo drug + sham tDCS

干预措施: tDCS sham (Device)

结局指标

主要结局

JTT

时间窗: crossover design, four different sessions with four different interventions

Jebsen Taylor test

次要结局

  • Force(crossover design, four different sessions with four different interventions)
  • NHPT(crossover design, four different sessions with four different interventions)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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