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临床试验/NCT02454218
NCT02454218Unknown1 期

Effect of Transcranial Direct-current Stimulation in Attentional Performance and Pain in Patients With Fibromyalgia

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
1 期
入组人数
40
试验地点
1
主要终点
Attention capacity after the intervention, assessed by the Attention Network Task

研究概览

简要总结

tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of 40 patients, divided into two groups with sham interventions and active crossover.

详细描述

Check that the tDCS can modify the attentional response of patients with fibromyalgia. Methods: This study deals with a randomized, blind, crossover, controlled tDCS-sham. The sample will consist of 40 patients, divided into two groups with sham interventions and active crossover. Patients answer the questionnaires in order to verify the Psychological Factors and Clinical. Will use the Impact of Fibromyalgia (QIF), Pittsburgh Sleep Questionnaire, Conditioned Pain Modulation (CPM), Beck Depression Scale II, Catastrophic Scale , Go noGo Test, Attention Network Task (ANT) to verify the ability attentional as well as to verify the Near-infrared spectroscopy (NIRS) brain oxygenation. They will be used before, during and after the intervention with tDCS. Intervention with tDCS or sham will be held in a single session. Expected results: It is expected that fibromyalgia patients undergoing tDCS present, after the intervention, improved attention capacity .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients, literate, right-handed, 18 to 65 years of age, who meet the criteria of the American College of Rheumatology (ACR) for fibromyalgia.

排除标准

  • Pregnant women
  • Contraindications to tDCS
  • Metal implant in the brain
  • History of alcohol or drug abuse in the last six months
  • Suffer from severe depression (score> 30 on the Beck Depression Inventory)
  • History of neurological disorders
  • Unexplained fainting
  • Self-reports of head injury or momentary loss of awareness
  • Neurosurgery.
  • Will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).

结局指标

主要结局

Attention capacity after the intervention, assessed by the Attention Network Task

时间窗: 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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