Back to results

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

Primary Purpose

Inflammatory Bowel Disease

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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 magnetic resonance imaging (MRI)
Pregnancy
Sever internal or psychiatric condition

Sites / Locations

Charite University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Active transcranial direct current stimulation

Sham transcranial direct current stimulation

Outcomes

Primary Outcome Measures

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

Participants will be followed for 2 weeks

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

Participants will be followed for 2 weeks

Secondary Outcome Measures

Changes in quality of life

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

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

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

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

Changes in pain catastophizing scale

Changes in inflammation bBlood)

Changes in inflammation (stool - calprotectin)

Full Information

NCT ID

NCT02433470

First Posted

April 25, 2015

Last Updated

January 23, 2018

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02433470

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS

Arm Type

Active Comparator

Arm Description

Active transcranial direct current stimulation

Arm Title

Sham tDCS

Arm Type

Sham Comparator

Arm Description

Sham transcranial direct current stimulation

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation

Other Intervention Name(s)

tDCS

Intervention Description

Transcranial direct current stimulation over the motor cortex

Primary Outcome Measure Information:

Title

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

Description

Participants will be followed for 2 weeks

Time Frame

1 week

Title

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

Description

Participants will be followed for 2 weeks

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Changes in quality of life

Time Frame

2 weeks

Title

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

Description

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

Time Frame

2 weeks

Title

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

Description

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

Time Frame

2 weeks

Title

Changes in pain catastophizing scale

Time Frame

2 weeks

Title

Changes in inflammation bBlood)

Time Frame

2 weeks

Title

Changes in inflammation (stool - calprotectin)

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magdalena S Prüß-Volz, MD

Organizational Affiliation

Charite University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charite University Medicine

City

Berlin

ZIP/Postal Code

12200

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs