Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

Conditions
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Constipation

Intervention / Treatment
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* Device: Functional Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 constipation defined by the Rome II criteria Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>FMS will be administered for 5 weeks | Device: Functional Magnetic Stimulation<br>* 20 minute stimulation will be applied 5 days a week for 5 weeks<br>* Other names: Commericially available magnetic stimulations with round magnetic coils.;|
| Sham Comparator: Sham<br>FMS at 5% intensity for 5 weeks | Device: Functional Magnetic Stimulation<br>* 20 minute stimulation will be applied 5 days a week for 5 weeks<br>* Other names: Commericially available magnetic stimulations with round magnetic coils.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol |  | 5 weeks after conditioning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period |  | 5 weeks after conditioning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, gastric emptying