ConstipationNCT01786837
Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
A study testing Functional Magnetic Stimulation in people with Constipation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Constipation
- What is being tested?
- Functional Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Oct 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- constipation defined by the Rome II criteria
Who cannot join
- Past history of abdominal surgery
- past history of diabetes mellitus
- past history of hypothyroidism
- past history of inflammatory bowel disease
- past history of significant psychiatric disturbances
- past history of drug abuse
Show all 12Show fewer
- past history of cardiac pacemakers
- past history of metal implants
- patients who cannot travel to keep the follow up
- patients who are prisoners
- patients who are mentally handicapped
- patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Digestive Disease Institute
Cleveland, Ohio, 44195
About this study
Official title: A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.
Read the detailed description
The goal of this pilot study is to evaluate the usefulness of FMS as a noninvasive method to stimulate the GI motility in individuals with non-neurological constipation by adopting a 5-week conditioning protocol performed in a hospital outpatient setting. FMS has demonstrated the ability to generate significant rectal pressure and enhance GI transit in normal and spinal cord injury subjects. With proper abdominal muscle conditioning, FMS may improve colonic motility partly due to improved abdominal muscle tone.
- Conditions
- Constipation
- Being tested
- Functional Magnetic Stimulation
- Keywords
- constipation, gastric emptying
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic StimulationDevice
Also called Commericially available magnetic stimulations with round magnetic coils.
20 minute stimulation will be applied 5 days a week for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | FMS will be administered for 5 weeks Receives: Device: Functional Magnetic Stimulation |
| Sham | Sham comparator | FMS at 5% intensity for 5 weeks Receives: Device: Functional Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol
Measured: 5 weeks after conditioning
Secondary outcomes (1)
Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period
Measured: 5 weeks after conditioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massarat Zutshi, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786837
- Sponsor's protocol ID
- 11-182
- Other IDs
- W81XWH-11-1-0707
- Status last verified
- Feb 2016
- First submitted
- 6 Feb 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT01786837
- Acronym / sponsor ID
- 11-182
- Conditions
- Constipation
- Keywords
- constipation, gastric emptying
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Feb 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 effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.
Detailed description
The goal of this pilot study is to evaluate the usefulness of FMS as a noninvasive method to stimulate the GI motility in individuals with non-neurological constipation by adopting a 5-week conditioning protocol performed in a hospital outpatient setting. FMS has demonstrated the ability to generate significant rectal pressure and enhance GI transit in normal and spinal cord injury subjects. With proper abdominal muscle conditioning, FMS may improve colonic motility partly due to improved abdominal muscle tone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Functional Magnetic StimulationFMS will be administered for 5 weeks |
| Sham | Sham comparator | Device: Functional Magnetic StimulationFMS at 5% intensity for 5 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80
- constipation defined by the Rome II criteria
Key exclusion criteria (12 listed)
- Past history of abdominal surgery
- past history of diabetes mellitus
- past history of hypothyroidism
- past history of inflammatory bowel disease
- past history of significant psychiatric disturbances
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 |
|---|---|---|
| Functional Magnetic StimulationAlso: Commericially available magnetic stimulations with round magnetic coils.20 minute stimulation will be applied 5 days a week for 5 weeks | Device | Sham, Treatment |
Primary outcome
Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol
Time frame: 5 weeks after conditioning
1 secondary outcome
Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period
Time frame: 5 weeks after conditioning
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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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.
Massarat Zutshi, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Magnetic Stimulation in people with Constipation, run by The Cleveland Clinic at 1 site in United States.
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 2 inclusion and 12 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: withdrawn, as of the sponsor's last update on 3 Feb 2016. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol (time frame: 5 weeks after conditioning). 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 3 Feb 2016.