Back to resultsAssociation Between Functional Changes in the Brain and the Perception of Pain in Patients With Inflammatory Bowel Diseases (IBD) - Measured With Functional Magnetic Resonance Imaging.
Primary Purpose
Inflammatory Bowel Diseases
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
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
Sites / Locations
- Charité 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 and/or structural changes in the brain measured with cerebral MRI
Participants will be followed for 2 weeks
Changes in pain measured with visual analogue scale
Participants will be followed for 2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
Participants will be followed for 2 weeks
Secondary Outcome Measures
Changes in questionnaire "quality of life"
questionnaire
Changes in functional symptoms
Questionnarie: irritable bowel syndrome - severity scoring system (IBS-SSS)
Changes in activity indices
Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index
Changes in pain catastophizing scale
Changes in inflammation biomarker (blood - C-reactive protein)
Changes in inflammation biomarker (stool - calprotectin)
Full Information
NCT ID
NCT03348852
First Posted
May 22, 2017
Last Updated
September 24, 2021
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT03348852
Brief Title
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.
Official Title
Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 24, 2017 (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
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 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.
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 2, 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)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Device: Transcranial direct current stimulation 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
2 week
Title
Changes in pain measured with visual analogue scale
Description
Participants will be followed for 2 weeks
Time Frame
2 weeks
Title
Changes in perception of pain measured with an algometer (pain pressure threshold)
Description
Participants will be followed for 2 weeks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Changes in questionnaire "quality of life"
Description
questionnaire
Time Frame
2 weeks
Title
Changes in functional symptoms
Description
Questionnarie: irritable bowel syndrome - severity scoring system (IBS-SSS)
Time Frame
2 weeks
Title
Changes in activity indices
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 biomarker (blood - C-reactive protein)
Time Frame
2 weeks
Title
Changes in inflammation biomarker (stool - calprotectin)
Time Frame
2 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
Charité 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
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.
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