Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)
Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
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
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Berlin、德国、12200
- 招聘中
- Charité University Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Inflammatory bowel disease
- Chronic pain (more than 3 months)
- Pain (VAS > 3/10)
Exclusion Criteria:
- Contraindication to transcranial direct current stimulation
- Contraindications to functional magnetic resonance imaging (fMRI)
- Pregnancy
- Sever internal or psychiatric condition
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：主动 tDCS
主动经颅直流电刺激
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Sham OR active transcranial direct current stimulation over the motor cortex
其他名称：
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假比较器：假 tDCS
假经颅直流电刺激
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Sham OR active transcranial direct current stimulation over the motor cortex
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional changes in the brain measured with cerebral MRI
大体时间：6 weeks
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Exploratory analyses of resting-state fMRI
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6 weeks
|
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Structural changes in the brain measured with cerebral MRI
大体时间：6 weeks
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Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)
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6 weeks
|
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Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
大体时间：6 weeks
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6 weeks
|
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Changes in pain measured with visual analogue scale
大体时间：6 weeks
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VAS , scale from 0-10
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6 weeks
|
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Changes in perception of pain measured with an algometer (pain pressure threshold)
大体时间：6 weeks
|
continuous scale form 0 kg
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6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in questionnaire "quality of life"
大体时间：6 weeks
|
questionnaire "quality of life" analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)
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6 weeks
|
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Changes in functional symptoms using IBS-SSS
大体时间：6 weeks
|
IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)
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6 weeks
|
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Changes in activity indices using HWI questionnaire or SCCAI questionnaire
大体时间：6 weeks
|
HWI: Harvey-Bradshaw-Index, SCCAI: Simple Clinical Colitis Activity Index, scale: points: 0-20 points (low points are best outcome, high points are worst outcome)
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6 weeks
|
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Changes in pain catastrophizing scale questionnaire
大体时间：6 weeks
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pain catastrophizing scale questionnaire analyses subjective catastrophizing due to pain, score running from 0-52 points (low points are best outcome, high points are worst outcome)
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6 weeks
|
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Changes in inflammation biomarker (blood - C-reactive protein)
大体时间：6 weeks
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unit: mg/dl
|
6 weeks
|
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Changes in inflammation biomarker (stool - calprotectin)
大体时间：6 weeks
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Unit: mg/g
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6 weeks
|
合作者和调查者
调查人员
- 首席研究员：Magdalena S Prüß-Volz, MD、Charité University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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