Inflammatory Bowel DiseasesPhase 2/3NCT03348852
Association Between Functional Changes in the Brain and the Perception of Pain in Patients With Inflammatory Bowel Diseases (IBD) - Measured With Functional Magnetic Resonance Imaging.
A Phase 2/3 study testing Transcranial direct current stimulation in people with 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 functional magnetic resonance imaging (fMRI) in patients with chronic inflammatory bowel diseases (IBD). 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
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2017to 30 Dec 2022
- Phase
- Phase 2/3
- 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
Charité University Medicine
Berlin, 12200
Magdalena S Prüß-Volz, MD, +493084452718, magdalena.pruess@charite.de
About this study
Official title: Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
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 functional magnetic resonance imaging (fMRI) 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 fMRI.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- 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.
Transcranial direct current stimulationDevice
Also called tDCS
Device: Transcranial direct current stimulation 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: Transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Sham transcranial direct current stimulation Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and/or structural changes in the brain measured with cerebral MRI
Participants will be followed for 2 weeks
Measured: 2 week
Changes in pain measured with visual analogue scale
Participants will be followed for 2 weeks
Measured: 2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
Participants will be followed for 2 weeks
Measured: 2 weeks
Secondary outcomes (6)
Changes in questionnaire "quality of life"
questionnaire
Measured: 2 weeks
Changes in functional symptoms
Questionnarie: irritable bowel syndrome - severity scoring system (IBS-SSS)
Measured: 2 weeks
Changes in activity indices
Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index
Measured: 2 weeks
Changes in pain catastophizing scale
Measured: 2 weeks
Changes in inflammation biomarker (blood - C-reactive protein)
Measured: 2 weeks
Changes in inflammation biomarker (stool - calprotectin)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start24 Jan 2017
- 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 2/3
- 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
- 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
- NCT03348852
- Sponsor's protocol ID
- EA4/017/16
- Status last verified
- Sep 2021
- First submitted
- 22 May 2017
- 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
- Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
- ClinicalTrials.gov ID
- NCT03348852
- Acronym / sponsor ID
- EA4/017/16
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Nov 2017 (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 functional magnetic resonance imaging (fMRI) 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 fMRI.
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: Transcranial direct current stimulationActive transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Device: 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 |
|---|---|---|
| Transcranial direct current stimulationAlso: tDCSDevice: Transcranial direct current stimulation Transcranial direct current stimulation over the motor cortex. | Device | Active tDCS, Sham tDCS |
Primary outcome
Functional and/or structural changes in the brain measured with cerebral MRI
Time frame: 2 week
Participants will be followed for 2 weeks
Changes in pain measured with visual analogue scale
Time frame: 2 weeks
Participants will be followed for 2 weeks
Changes in perception of pain measured with an algometer (pain pressure threshold)
Time frame: 2 weeks
Participants will be followed for 2 weeks
6 secondary outcomes
Changes in questionnaire "quality of life"
Time frame: 2 weeks
Changes in functional symptoms
Time frame: 2 weeks
Changes in activity indices
Time frame: 2 weeks
Changes in pain catastophizing scale
Time frame: 2 weeks
Changes in inflammation biomarker (blood - C-reactive protein)
Time frame: 2 weeks
Changes in inflammation biomarker (stool - calprotectin)
Time frame: 2 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 2/3 study testing Transcranial direct current stimulation in people with 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 and/or structural changes in the brain measured with cerebral MRI (time frame: 2 week). The study lists 3 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.