Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01786837
• Other study ID #: 11-182
• Secondary ID: W81XWH-11-1-0707
• Status: Withdrawn
• Phase: N/A
• First received: February 6, 2013
• Last updated: February 2, 2016
• Start date: December 2012
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Device:
• Functional Magnetic Stimulation
20 minute stimulation will be applied 5 days a week for 5 weeks

Locations

Country	Name	City	State
United States	Cleveland Clinic Digestive Disease Institute	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol		5 weeks after conditioning	No
Secondary	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	No