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Completed

NCT Number: NCT02433470

Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)

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.

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite University Medicine

Berlin, 12200, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 magnetic resonance imaging (MRI)
  • Pregnancy
  • Sever internal or psychiatric condition

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Transcranial direct current stimulation over the motor cortex

Other names: tDCS

Primary outcomes

  1. Functional and/or structural changes in the brain measured with cerebral MRI

    Time frame: 1 week

    Participants will be followed for 2 weeks

  2. Changes in perception of pain measured with visual analogue scale and pain pressure threshold

    Time frame: 2 weeks

    Participants will be followed for 2 weeks

Secondary outcomes

  1. Changes in quality of life

    Time frame: 2 weeks

  2. Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))

    Time frame: 2 weeks

    Questionnaire: irritable bowel syndrome - severity scoring system (IBS-SSS)

  3. Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)

    Time frame: 2 weeks

    (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)

  4. Changes in pain catastophizing scale

    Time frame: 2 weeks

  5. Changes in inflammation bBlood)

    Time frame: 2 weeks

  6. Changes in inflammation (stool - calprotectin)

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
May 5, 2015
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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