Irritable Bowel SyndromePhase 2NCT01801605
Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome
A Phase 2 study testing rTMS in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS) in a prospective, randomized, double-blind study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- rTMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2008to Jan 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than 18 years old
- IBS defined by Rome III criteria
- Rectal hypersensitivity evaluated by barotat with a pain or inconfort volume less than 28 mmHg
- IBS for more than 3 months
- With an organic exploration for less than 6 months
- Without any knowledge concerning the rTMS
Who cannot join
- Pregnant women or women without any contraception
- Patients with pace-maker or other metallic implant
- Patients complaining of epilepsia or with past of epilepsia
- Patients with psychiatric disorders
- Patients treated by any drugs which could interfere with rTMS
- Patients having participate to another protocol within the month preceeding the inclusion
- Patients who could not stop the antalgic drugs within the week preceeding the onset of the study
- patients with a significant lesion on RMI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?
The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS) in a prospective, randomized, double-blind study.
Read the detailed description
IBS patients frequently demonstrate a rectal hypersensitivity which could participate to the abdominal pain. rTMS is an effective treatment of neurogenic chronic pain. The aim of the study is to evaluate the efficacy of rTMS on rectal hypersensitivity in patients with IBS in a prospective, randomized, double-blind study.
Patients and method: 20 patients with rectal hypersensitivity secondary to IBS will have one active session of rTMS located on the cortical area of the abdominal muscles during 5 consecutive days and one session of simulated rTMS during 5 over consecutive days corresponding to the placebo session. The order of the two session will be randomized. The efficacy of rTMS will be assessed by a rectal barostat to determine the pain or discomfort threshold and by a RIII reflex. The barostat and RIII reflex will be performed at the beginning and at the end of each session.
The investigators hope to demonstrate an improvement of the rectal hypersensitivity during the active stimulations compared to the placebo one.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- rTMS
- Keywords
- IBS - rectal hypersensitivity - rectal barostat - rTMS.
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSProcedure or surgery
Also called Active:A, Placebo:B
Active session with stimulation and placebo session with fictive stimulation
| Study group | Role | What they receive |
|---|---|---|
| on | Active comparator | active session Receives: Procedure: rTMS |
| off | Placebo comparator | fictive session Receives: Procedure: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain or discomfort threshold volumes
Measured: final (up to 5 days)
Secondary outcomes (4)
Amplitude of R3 reflex
Visual analogic scale
Symptoms diary
Quality of life scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startAug 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie Leroi, phD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801605
- Sponsor's protocol ID
- 2007/053/HP
- Other IDs
- 2007-A00799-44
- Status last verified
- Feb 2013
- First submitted
- 17 Feb 2009
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?
- ClinicalTrials.gov ID
- NCT01801605
- Acronym / sponsor ID
- 2007/053/HP
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS - rectal hypersensitivity - rectal barostat - rTMS.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Mar 2013 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS) in a prospective, randomized, double-blind study.
Detailed description
IBS patients frequently demonstrate a rectal hypersensitivity which could participate to the abdominal pain. rTMS is an effective treatment of neurogenic chronic pain. The aim of the study is to evaluate the efficacy of rTMS on rectal hypersensitivity in patients with IBS in a prospective, randomized, double-blind study.
Patients and method: 20 patients with rectal hypersensitivity secondary to IBS will have one active session of rTMS located on the cortical area of the abdominal muscles during 5 consecutive days and one session of simulated rTMS during 5 over consecutive days corresponding to the placebo session. The order of the two session will be randomized. The efficacy of rTMS will be assessed by a rectal barostat to determine the pain or discomfort threshold and by a RIII reflex. The barostat and RIII reflex will be performed at the beginning and at the end of each session.
The investigators hope to demonstrate an improvement of the rectal hypersensitivity during the active stimulations compared to the placebo one.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on | Active comparator | Procedure: rTMSactive session |
| off | Placebo comparator | Procedure: rTMSfictive session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- more than 18 years old
- IBS defined by Rome III criteria
- Rectal hypersensitivity evaluated by barotat with a pain or inconfort volume less than 28 mmHg
- IBS for more than 3 months
- With an organic exploration for less than 6 months
Key exclusion criteria (8 listed)
- Pregnant women or women without any contraception
- Patients with pace-maker or other metallic implant
- Patients complaining of epilepsia or with past of epilepsia
- Patients with psychiatric disorders
- Patients treated by any drugs which could interfere with rTMS
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 |
|---|---|---|
| rTMSAlso: Active:A, Placebo:BActive session with stimulation and placebo session with fictive stimulation | Procedure or surgery | off, on |
Primary outcome
Pain or discomfort threshold volumes
Time frame: final (up to 5 days)
4 secondary outcomes
Amplitude of R3 reflex
Visual analogic scale
Symptoms diary
Quality of life scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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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.
Anne-Marie Leroi, phD principal investigator
CHU Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rTMS in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 1 Mar 2013. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain or discomfort threshold volumes (time frame: final (up to 5 days)). 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 1 Mar 2013.