NCT01786837

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

February 6, 2013

Last Update Submit

February 2, 2016

Conditions

Constipation

Keywords

constipationgastric emptying

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of FMS in accelerating the gastric emptying in patients with non-neurological constipation after 5-week conditioning protocol

    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

    5 weeks after conditioning

Study Arms (2)

Treatment

EXPERIMENTAL

FMS will be administered for 5 weeks

Device: Functional Magnetic Stimulation

Sham

SHAM COMPARATOR

FMS at 5% intensity for 5 weeks

Device: Functional Magnetic Stimulation

Interventions

Functional Magnetic StimulationDEVICE

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

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Digestive Disease Institute

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Massarat Zutshi, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

December 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(1)