A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Constipation
- Sponsor
- The Cleveland Clinic
- Locations
- 1
- Primary Endpoint
- Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)