Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
试验速览
- 阶段
- 3 期
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Functional changes in the brain measured with cerebral MRI
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) and also with a change in permeability of the intestinal epithelial barrier 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. Additionally, transcranial direct current stimulation and the induced pain reduction influence the permeability of the intestinal epithelial barrier
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 80 Years（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 functional magnetic resonance imaging (fMRI)
- •Pregnancy
- •Sever internal or psychiatric condition
结局指标
主要结局
Functional changes in the brain measured with cerebral MRI
时间窗: 6 weeks
Exploratory analyses of resting-state fMRI
Changes in perception of pain measured with an algometer (pain pressure threshold)
时间窗: 6 weeks
continuous scale form 0 kg
Structural changes in the brain measured with cerebral MRI
时间窗: 6 weeks
Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)
Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
时间窗: 6 weeks
Changes in pain measured with visual analogue scale
时间窗: 6 weeks
VAS , scale from 0-10
次要结局
- Changes in functional symptoms using IBS-SSS(6 weeks)
- Changes in inflammation biomarker (blood - C-reactive protein)(6 weeks)
- Changes in inflammation biomarker (stool - calprotectin)(6 weeks)
- Changes in pain catastrophizing scale questionnaire(6 weeks)
- Changes in questionnaire "quality of life"(6 weeks)
- Changes in activity indices using HWI questionnaire or SCCAI questionnaire(6 weeks)
研究者
Magdalena S. Prüß née Volz
Principal Investigator, MD
Charite University, Berlin, Germany