Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

February 2, 2016 updated by: The Cleveland Clinic

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Digestive Disease Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
FMS will be administered for 5 weeks
Device: Functional Magnetic Stimulation
20 minute stimulation will be applied 5 days a week for 5 weeks
Other Names:
  • Commericially available magnetic stimulations with round magnetic coils.
SHAM_COMPARATOR: Sham
FMS at 5% intensity for 5 weeks
Device: Functional Magnetic Stimulation
20 minute stimulation will be applied 5 days a week for 5 weeks
Other Names:
  • Commericially available magnetic stimulations with round magnetic coils.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 weeks after conditioning

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 weeks after conditioning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (ESTIMATE)

February 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-182
  • W81XWH-11-1-0707 (OTHER_GRANT: DOD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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