Inflammatory Bowel DiseasesPhase 3NCT03825900
Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)
A Phase 3 study of Inflammatory Bowel Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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 magnetic resonance imaging (MRI) and also with a change in permeability of the intestinal epithelial barrier in patients with… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inflammatory bowel disease
- Chronic pain (more than 3 months)
- Pain (VAS > 3/10)
Who cannot join
- Contraindication to transcranial direct current stimulation
- Contraindications to functional magnetic resonance imaging (fMRI)
- Pregnancy
- Sever internal or psychiatric condition
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University Medicine
Berlin, 12200
Magdalena S Prüß-Volz, MD, +493084452718, magdalena.pruess@charite.de
About this study
Official title: Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
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
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Sham OR active Transcranial direct current stimulation
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham OR active Transcranial direct current stimulationDevice
Also called Sham OR active tDCS
Sham OR active transcranial direct current stimulation over the motor cortex
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Active transcranial direct current stimulation Receives: Device: Sham OR active Transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Sham transcranial direct current stimulation Receives: Device: Sham OR active Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional changes in the brain measured with cerebral MRI
Exploratory analyses of resting-state fMRI
Measured: 6 weeks
Structural changes in the brain measured with cerebral MRI
Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)
Measured: 6 weeks
Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
Measured: 6 weeks
Changes in pain measured with visual analogue scale
VAS , scale from 0-10
Measured: 6 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
continuous scale form 0 kg
Measured: 6 weeks
Secondary outcomes (6)
Changes in questionnaire "quality of life"
questionnaire "quality of life" analyses daily activities, scale running from 32 points (worse outcome) to 224 points (best outcome)
Measured: 6 weeks
Changes in functional symptoms using IBS-SSS
IBS-SSS: irritable bowel syndrome - severity score system , questionnaire analyses functional symptoms, score running from 0 (best outcome) until 600 points (worst outcome)
Measured: 6 weeks
Changes in activity indices using HWI questionnaire or SCCAI questionnaire
HWI: Harvey-Bradshaw-Index, SCCAI: Simple Clinical Colitis Activity Index, scale: points: 0-20 points (low points are best outcome, high points are worst outcome)
Measured: 6 weeks
Changes in pain catastrophizing scale questionnaire
pain catastrophizing scale questionnaire analyses subjective catastrophizing due to pain, score running from 0-52 points (low points are best outcome, high points are worst outcome)
Measured: 6 weeks
Changes in inflammation biomarker (blood - C-reactive protein)
unit: mg/dl
Measured: 6 weeks
Changes in inflammation biomarker (stool - calprotectin)
Unit: mg/g
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Jun 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Magdalena S. Prüß née Volz, Charite University, Berlin, Germany
- Investigators
- Magdalena S Prüß-Volz, MD, Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825900
- Sponsor's protocol ID
- EA4/221/17
- Status last verified
- Sep 2021
- First submitted
- 25 Jun 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
- ClinicalTrials.gov ID
- NCT03825900
- Acronym / sponsor ID
- EA4/221/17
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Sham OR active Transcranial direct current stimulationActive transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Device: Sham OR active Transcranial direct current stimulationSham transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inflammatory bowel disease
- Chronic pain (more than 3 months)
- Pain (VAS > 3/10)
Key exclusion criteria (4 listed)
- Contraindication to transcranial direct current stimulation
- Contraindications to functional magnetic resonance imaging (fMRI)
- Pregnancy
- Sever internal or psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham OR active Transcranial direct current stimulationAlso: Sham OR active tDCSSham OR active transcranial direct current stimulation over the motor cortex | Device | Active tDCS, Sham tDCS |
Primary outcome
Functional changes in the brain measured with cerebral MRI
Time frame: 6 weeks
Exploratory analyses of resting-state fMRI
Structural changes in the brain measured with cerebral MRI
Time frame: 6 weeks
Exploratory analyses of MRI with respect to DTI (diffusions tensor imaging) and VBM (voxel based morphometry)
Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
Time frame: 6 weeks
Changes in pain measured with visual analogue scale
Time frame: 6 weeks
VAS , scale from 0-10
Changes in perception of pain measured with an algometer (pain pressure threshold)
Time frame: 6 weeks
continuous scale form 0 kg
6 secondary outcomes
Changes in questionnaire "quality of life"
Time frame: 6 weeks
Changes in functional symptoms using IBS-SSS
Time frame: 6 weeks
Changes in activity indices using HWI questionnaire or SCCAI questionnaire
Time frame: 6 weeks
Changes in pain catastrophizing scale questionnaire
Time frame: 6 weeks
Changes in inflammation biomarker (blood - C-reactive protein)
Time frame: 6 weeks
Changes in inflammation biomarker (stool - calprotectin)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena S Prüß-Volz, MD principal investigator
Charite University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Inflammatory Bowel Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena S Prüß-Volz, MD (+493084452718, magdalena.pruess@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional changes in the brain measured with cerebral MRI (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.