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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01786837
Enrollment
0
Registered
2013-02-08
Start date
2012-12-31
Completion date
2015-10-31
Last updated
2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

constipation, gastric emptying

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.

Interventions

20 minute stimulation will be applied 5 days a week for 5 weeks

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol5 weeks after conditioning

Secondary

MeasureTime frame
Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period5 weeks after conditioning

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026