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

NCT ID: NCT02433470

Last Updated: 2018-01-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active tDCS

Active transcranial direct current stimulation

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation over the motor cortex

Sham tDCS

Sham transcranial direct current stimulation

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation over the motor cortex

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial direct current stimulation

Transcranial direct current stimulation over the motor cortex

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tDCS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Magdalena S. Prüß née Volz

Dr. med. Magdalena Sarah Prüß (geb. Volz)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Magdalena S Prüß-Volz, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charite University Medicine

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EA4/028/15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brain Connectivity in Depression
NCT03276793 RECRUITING NA
fMRI Study of tES in Major Depression
NCT04031547 COMPLETED EARLY_PHASE1