Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-10-31

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.

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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.

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

FMS will be administered for 5 weeks

Group Type EXPERIMENTAL

Functional Magnetic Stimulation

Intervention Type DEVICE

20 minute stimulation will be applied 5 days a week for 5 weeks

Sham

FMS at 5% intensity for 5 weeks

Group Type SHAM_COMPARATOR

Functional Magnetic Stimulation

Intervention Type DEVICE

20 minute stimulation will be applied 5 days a week for 5 weeks

Interventions

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Functional Magnetic Stimulation

20 minute stimulation will be applied 5 days a week for 5 weeks

Intervention Type DEVICE

Other Intervention Names

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Commericially available magnetic stimulations with round magnetic coils.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No