Association Between Functional Changes in the Brain and the Perception of Pain in Patients With Inflammatory Bowel Diseases (IBD) - Measured With Functional Magnetic Resonance Imaging.

Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03348852

Enrollment

Registered

2017-11-21

Start date

2017-01-24

Completion date

2022-12-30

Last updated

2021-09-27

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

Conditions

Inflammatory Bowel Diseases

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 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.

Interventions

DEVICETranscranial direct current stimulation

Device: Transcranial 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 80 Years

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 functional magnetic resonance imaging (fMRI) * 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	2 week	Participants will be followed for 2 weeks
Changes in pain measured with visual analogue scale	2 weeks	Participants will be followed for 2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)	2 weeks	Participants will be followed for 2 weeks

Secondary

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

Countries

Germany

Contacts

Primary ContactMagdalena S Prüß-Volz, MD

magdalena.pruess@charite.de+493084452718

Outcome results

None listed

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