Effectiveness of Transcranial Direct Current Stimulation for the Treatment of Functional Dyspepsia: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- PADYQ score
研究概览
简要总结
Functional dyspepsia is a very common disorder of great challenge to clinical management. A therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct current stimulation (tDCS) is a novel therapy that pursues these properties, besides its safety and easy adherence. There is a great need of new treatments for functional dyspepsia. There is no current study evaluating tDCS for this disease.
详细描述
Functional dyspepsia is a high prevalent disease with substantial costs to health system. There are many available treatments, but disappointing results are reported in clinical trials.
TDCS is a noninvasive, secure and painless technique of brain stimulation. It is delivered by a battery-operated device that transfers low intensity electrical current to all surface of the brain. Then there is a modulation of cortical excitability and influence on central neurological functions. It has been reported its efficacy for the treatment of many diseases such as depression and chronic pain.
Impairment of central mechanisms of interpretation and threshold of pain are related to functional dyspepsia. Therefore, tDCS may benefit dyspeptic patients.
This study is a double blind randomized controled trial to test tDCS effectiveness on functional dyspepsia. Seventy functional dyspeptic patients will be enrolled, being randomized to either tDCS or sham tDCS.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •functional dyspeptic patients according to Rome IV criteria
- •clinical investigation reporting absence of organic causes of functional dyspepsia
排除标准
- •history of brain trauma, haemorrhage or ischemia
- •implantable devices such as pacemaker
- •alcohol or drug abuse
- •severe chronic disease
- •non-acceptance to sign up the term of consent.
研究组 & 干预措施
anodal tDCS
TDCS will be delivered with two saline-soaked sponge electrodes. The main electrode to anodal stimulation will be placed over the motor cortex, M1. The second electrode is neutral and will be placed on the skin overlying the supraorbital region The current will be delivered at the intensity of 2mA for 20 minutes. The procedure will be repeated at five consecutive days.
干预措施: anodal tDCS (Device)
Sham tDCS
Two electrodes are positioned at M1 and supra-orbital área. To deliver sham, the current will be delivered for 30 sec only to elicit tingling skin sensation but no cortical excitability changes. The procedure will be repeated at five consecutive days.
干预措施: Sham tDCS (Device)
结局指标
主要结局
PADYQ score
时间窗: 4 weeks
Decrease in PADYQ (Porto Alegre Dyspepsia Symptoms Questionnaire) score
次要结局
- SF36 score(4 weeks)
- Use of drugs for dyspeptic symptoms(1 and 4 weeks)
- Self-reported treatment response(1 and 4 weeks)
- HADS score(4 weeks)
研究者
Carine Leite
Carine Leite, MD
Hospital Ernesto Dornelles