Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
试验速览
- 阶段
- 2 期
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Functional and/or structural 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 functional magnetic resonance imaging (fMRI) 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 fMRI.
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 and/or structural changes in the brain measured with cerebral MRI
时间窗: 2 week
Participants will be followed for 2 weeks
Changes in pain measured with visual analogue scale
时间窗: 2 weeks
Participants will be followed for 2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
时间窗: 2 weeks
Participants will be followed for 2 weeks
次要结局
- Changes in pain catastophizing scale(2 weeks)
- Changes in questionnaire "quality of life"(2 weeks)
- Changes in functional symptoms(2 weeks)
- Changes in activity indices(2 weeks)
- Changes in inflammation biomarker (blood - C-reactive protein)(2 weeks)
- Changes in inflammation biomarker (stool - calprotectin)(2 weeks)
研究者
Magdalena S. Prüß née Volz
Dr. med. Magdalena Sarah Prüß (geb. Volz)
Charite University, Berlin, Germany