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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02433470

Enrollment

Registered

2015-05-05

Start date

2015-04-30

Completion date

Unknown

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Brief summary

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.

Interventions

DEVICETranscranial direct current stimulation

Transcranial direct current stimulation over the motor cortex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Functional and/or structural changes in the brain measured with cerebral MRI	1 week	Participants will be followed for 2 weeks
Changes in perception of pain measured with visual analogue scale and pain pressure threshold	2 weeks	Participants will be followed for 2 weeks

Secondary

Measure	Time frame	Description
Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)	2 weeks	(Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)
Changes in pain catastophizing scale	2 weeks	—
Changes in quality of life	2 weeks	—
Changes in inflammation (stool - calprotectin)	2 weeks	—
Changes in inflammation bBlood)	2 weeks	—
Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))	2 weeks	Questionnaire: irritable bowel syndrome - severity scoring system (IBS-SSS)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026