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Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Primary Purpose

Inflammatory Bowel Diseases

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Sham OR active Transcranial direct current stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 80 Years (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 functional magnetic resonance imaging (fMRI)
  • Pregnancy
  • Sever internal or psychiatric condition

Sites / Locations

  • Charite University MedicineRecruiting

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 changes in the brain measured with cerebral MRI
Exploratory analyses of resting-state fMRI
Structural changes in the brain measured with cerebral MRI
Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)
Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
Changes in pain measured with visual analogue scale
VAS , scale from 0-10
Changes in perception of pain measured with an algometer (pain pressure threshold)
continuous scale form 0 kg

Secondary Outcome Measures

Changes in questionnaire "quality of life"
questionnaire "quality of life" analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)
Changes in functional symptoms using IBS-SSS
IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)
Changes in activity indices using HWI questionnaire or SCCAI questionnaire
HWI: Harvey-Bradshaw-Index, SCCAI: Simple Clinical Colitis Activity Index, scale: points: 0-20 points (low points are best outcome, high points are worst outcome)
Changes in pain catastrophizing scale questionnaire
pain catastrophizing scale questionnaire analyses subjective catastrophizing due to pain, score running from 0-52 points (low points are best outcome, high points are worst outcome)
Changes in inflammation biomarker (blood - C-reactive protein)
unit: mg/dl
Changes in inflammation biomarker (stool - calprotectin)
Unit: mg/g

Full Information

First Posted
June 25, 2018
Last Updated
September 24, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03825900
Brief Title
Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)
Official Title
Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

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) and also with a change in permeability of the intestinal epithelial barrier 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. Additionally, transcranial direct current stimulation and the induced pain reduction influence the permeability of the intestinal epithelial barrier

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (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)
Sham OR active Transcranial direct current stimulation
Other Intervention Name(s)
Sham OR active tDCS
Intervention Description
Sham OR active transcranial direct current stimulation over the motor cortex
Primary Outcome Measure Information:
Title
Functional changes in the brain measured with cerebral MRI
Description
Exploratory analyses of resting-state fMRI
Time Frame
6 weeks
Title
Structural changes in the brain measured with cerebral MRI
Description
Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)
Time Frame
6 weeks
Title
Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
Time Frame
6 weeks
Title
Changes in pain measured with visual analogue scale
Description
VAS , scale from 0-10
Time Frame
6 weeks
Title
Changes in perception of pain measured with an algometer (pain pressure threshold)
Description
continuous scale form 0 kg
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in questionnaire "quality of life"
Description
questionnaire "quality of life" analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)
Time Frame
6 weeks
Title
Changes in functional symptoms using IBS-SSS
Description
IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)
Time Frame
6 weeks
Title
Changes in activity indices using HWI questionnaire or SCCAI questionnaire
Description
HWI: Harvey-Bradshaw-Index, SCCAI: Simple Clinical Colitis Activity Index, scale: points: 0-20 points (low points are best outcome, high points are worst outcome)
Time Frame
6 weeks
Title
Changes in pain catastrophizing scale questionnaire
Description
pain catastrophizing scale questionnaire analyses subjective catastrophizing due to pain, score running from 0-52 points (low points are best outcome, high points are worst outcome)
Time Frame
6 weeks
Title
Changes in inflammation biomarker (blood - C-reactive protein)
Description
unit: mg/dl
Time Frame
6 weeks
Title
Changes in inflammation biomarker (stool - calprotectin)
Description
Unit: mg/g
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
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 functional magnetic resonance imaging (fMRI) Pregnancy Sever internal or psychiatric condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena S Prüß-Volz, MD
Phone
+493084452718
Email
magdalena.pruess@charite.de
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena S Prüß-Volz, MD
Phone
+493084452718
Email
magdalena.pruess@charite.de

12. IPD Sharing Statement

Learn more about this trial

Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)

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