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Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01786837
First received: February 6, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Constipation
Device: Functional Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Commericially available magnetic stimulations with round magnetic coils.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786837

Contacts
Contact: Massaat Zutshi, MD 216/445-9456 zutshim@ccf.org
Contact: Brook Gurland, MD 216/445-3604 gurlanb@ccf.org

Locations
United States, Ohio
Cleveland Clinic Digestive Disease Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Massarat Zutshi, MD    216-445-3604    zutshim@ccf.org   
Contact: Adele Costanzo, RN    216/445-3851    costanza@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Massarat Zutshi, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01786837     History of Changes
Other Study ID Numbers: 11-182, W81XWH-11-1-0707
Study First Received: February 6, 2013
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
constipation
gastric emptying

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2014