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Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients With Chronic Constipation

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Withdrawn

Conditions

Constipation

Treatments

Device: Functional Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01786837
W81XWH-11-1-0707
11-182

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Treatment
Experimental group
Description:
FMS will be administered for 5 weeks
Treatment:
Device: Functional Magnetic Stimulation
Sham
Sham Comparator group
Description:
FMS at 5% intensity for 5 weeks
Treatment:
Device: Functional Magnetic Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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