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.

Charité University Medicine Berlin

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03348852

EA4/017/16

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Active tDCS

Active Comparator group

Description:

Active transcranial direct current stimulation

Treatment:

Device: Transcranial direct current stimulation

Sham tDCS

Sham Comparator group

Description:

Sham transcranial direct current stimulation

Treatment:

Device: Transcranial direct current stimulation