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

NCT ID: NCT03825900

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-12-30

Brief Summary

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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

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active tDCS

Active transcranial direct current stimulation

Group Type ACTIVE_COMPARATOR

Sham OR active Transcranial direct current stimulation

Intervention Type DEVICE

Sham OR active transcranial direct current stimulation over the motor cortex

Sham tDCS

Sham transcranial direct current stimulation

Group Type SHAM_COMPARATOR

Sham OR active Transcranial direct current stimulation

Intervention Type DEVICE

Sham OR active transcranial direct current stimulation over the motor cortex

Interventions

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Sham OR active Transcranial direct current stimulation

Sham OR active transcranial direct current stimulation over the motor cortex

Intervention Type DEVICE

Other Intervention Names

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Sham OR active tDCS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Magdalena S. Prüß née Volz

Principal Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena S Prüß-Volz, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University

Locations

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Charite University Medicine

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Magdalena S Prüß-Volz, MD

Role: CONTACT

+493084452718

Facility Contacts

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Magdalena S Prüß-Volz, MD

Role: primary

+493084452718

Other Identifiers

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EA4/221/17

Identifier Type: -

Identifier Source: org_study_id

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