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WithdrawnNCT01786837Updated Feb 3, 2016

Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

An interventional study of Functional Magnetic Stimulation in Constipation, sponsored by The Cleveland Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-03.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Lack of enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Constipation

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Keywords

  • constipation
  • gastric emptying
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

Browse Constipation studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-80
  • constipation defined by the Rome II criteria

Exclusion 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment

    FMS will be administered for 5 weeks

    Device: Functional Magnetic Stimulation

  • Sham comparator
    Sham

    FMS at 5% intensity for 5 weeks

    Device: Functional Magnetic Stimulation

Interventions

  • DeviceFunctional Magnetic Stimulation

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

    Also known as: Commericially available magnetic stimulations with round magnetic coils.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • Cleveland Clinic Digestive Disease Institute
    Cleveland, Ohio 44195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01786837
Lead sponsor
The Cleveland Clinic
Responsible party
Sponsor
First posted
Feb 8, 2013
Start date
Dec 2012
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Feb 3, 2016

Study contacts

Massarat Zutshi, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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