Transcranial Direct Current Stimulation to Reduce Chronic Pain in Patients With Chronic Inflammatory Bowel Diseases (tDCS in IBD)

January 23, 2018 updated by: Magdalena S. Prüß née Volz, Charite University, Berlin, Germany

In the study we test whether transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases.

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charité University Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inflammatory bowel disease
  • Chronic pain (more than 3 months)
  • Pain (VAS > 3/10)

Exclusion Criteria:

  • Contraindication to transcranial direct current stimulation
  • Pregnancy
  • Sever internal or psychiatric condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham transcranial direct current stimulation
Device: Transcranial direct current stimulation
Active Comparator: Active transcranial direct current stimulation
Device: Transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain pressure threshold
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual analoug scale - pain
Time Frame: 1 week
1 week

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 11, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/135/13 (Other Identifier: Charité Universitätsmedizin Berlin)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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