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What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Constipation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Functional Magnetic Stimulation20 minute stimulation will be applied 5 days a week for 5 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

TreatmentFMS will be administered for 5 weeks

ShamFMS at 5% intensity for 5 weeks

Study Status

Withdrawn

Start Date: December 2012

Completed Date: October 2015

Phase: N/A

Type: Interventional

Design:

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

Secondary Outcome: Effectiveness of FMS in reducing the colonic transit time in patients with non-neurological constipation after a 5 week conditioning period

Study sponsors, principal investigator, and references

Principal Investigator: Massarat Zutshi, MD

Lead Sponsor: The Cleveland Clinic

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01786837