Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in perception of pain measured with visual analogue scale and pain pressure threshold
研究概览
简要总结
In the study the investigators aim to test whether transcranial direct current stimulation (tDCS)-induced pain reduction is in association with functional changes in the brain measured with magnetic resonance imaging (MRI) in patients with chronic inflammatory bowel diseases (IBD).
Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via MRI.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inflammatory bowel disease
- •Chronic pain (more than 3 months)
- •Pain (VAS > 3/10)
排除标准
- •Contraindication to transcranial direct current stimulation
- •Contraindications to magnetic resonance imaging (MRI)
- •Pregnancy
- •Sever internal or psychiatric condition
结局指标
主要结局
Changes in perception of pain measured with visual analogue scale and pain pressure threshold
时间窗: 2 weeks
Participants will be followed for 2 weeks
Functional and/or structural changes in the brain measured with cerebral MRI
时间窗: 1 week
Participants will be followed for 2 weeks
次要结局
- Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)(2 weeks)
- Changes in quality of life(2 weeks)
- Changes in pain catastophizing scale(2 weeks)
- Changes in inflammation bBlood)(2 weeks)
- Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))(2 weeks)
- Changes in inflammation (stool - calprotectin)(2 weeks)
研究者
Magdalena S. Prüß née Volz
Dr. med. Magdalena Sarah Prüß (geb. Volz)
Charite University, Berlin, Germany