Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

Not Applicable

Withdrawn

• Conditions: Constipation
• Interventions: Device: Functional Magnetic Stimulation

• Registration Number: NCT01786837
• Lead Sponsor: The Cleveland Clinic

Brief 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.

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Functional Magnetic Stimulation	FMS will be administered for 5 weeks
Sham	Functional Magnetic Stimulation	FMS at 5% intensity for 5 weeks

Primary Outcome Measures

Name	Time	Method
Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol	5 weeks after conditioning

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cleveland Clinic Digestive Disease Institute; 🇺🇸 Cleveland, Ohio, United States