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

Primary Purpose

Inflammatory Bowel Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
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 Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • Pregnancy
  • Sever internal or psychiatric condition

Sites / Locations

  • Charite University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active transcranial direct current stimulation

Sham transcranial direct current stimulation

Arm Description

Outcomes

Primary Outcome Measures

Pain pressure threshold

Secondary Outcome Measures

Visual analoug scale - pain

Full Information

First Posted
January 11, 2014
Last Updated
January 23, 2018
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02048137
Brief Title
Transcranial Direct Current Stimulation to Reduce Chronic Pain in Patients With Chronic Inflammatory Bowel Diseases
Acronym
tDCS in IBD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active transcranial direct current stimulation
Arm Type
Active Comparator
Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Pain pressure threshold
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Visual analoug scale - pain
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Quality of life
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Pregnancy Sever internal or psychiatric condition
Facility Information:
Facility Name
Charite University Medicine
City
Berlin
ZIP/Postal Code
12200
Country
Germany

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation to Reduce Chronic Pain in Patients With Chronic Inflammatory Bowel Diseases

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