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Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01786837
First received: February 6, 2013
Last updated: February 2, 2016
Last verified: February 2016

February 6, 2013
February 2, 2016
December 2012
October 2015   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01786837 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Constipation
Device: Functional Magnetic Stimulation
20 minute stimulation will be applied 5 days a week for 5 weeks
Other Name: Commericially available magnetic stimulations with round magnetic coils.
  • Experimental: Treatment
    FMS will be administered for 5 weeks
    Intervention: Device: Functional Magnetic Stimulation
  • Sham Comparator: Sham
    FMS at 5% intensity for 5 weeks
    Intervention: Device: Functional Magnetic Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01786837
11-182, W81XWH-11-1-0707
No
Not Provided
Not Provided
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Massarat Zutshi, MD The Cleveland Clinic
The Cleveland Clinic
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP