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Mechanism of Action of Biofeedback Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988286
First Posted: October 2, 2009
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Satish Rao, Augusta University
  Purpose

Biofeedback therapy improves bowel symptoms and anorectal function in patients with dyssynergic defecation, however its mechanism of action is not known. The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering cortical processing of information and improving cortically mediated neuromuscular function of the gut. The investigators' specific aims are; (1) To evaluate the afferent cortical evoked potentials in response to the electrical stimulation of the anorectum (i) before and after biofeedback therapy and (ii) compare responders with nonresponders. (2) To evaluate the corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses following noninvasive lumbosacral and transcranial magnetic stimulation (i) before and after biofeedback therapy and (ii) compare responders with nonresponders.

The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication and alters cortical and neuromuscular function. The investigators' specific aims are to evaluate 60 patients with dyssynergia (i) before and after biofeedback therapy and (ii) compare responders with nonresponders by examining:

(A) The afferent cortical evoked potentials using electrical stimulation of the anus and rectum.

(B) The efferent cortical evoked potentials by lumbosacral and transcranial magnetic stimulation and recording the anal and rectal electromyographic responses.


Condition Intervention
Constipation Hyposensitivity Hypersensitivity Procedure: CEP, MEP, TMS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mechanism of Action of Biofeedback Therapy

Further study details as provided by Satish Rao, Augusta University:

Primary Outcome Measures:
  • To evaluate the afferent cortical evoked potentials using electrical stimulation of the anus and rectum (i) before and after biofeedback therapy and (ii) compare responders with nonresponders. [ Time Frame: 2 visits of 3 hours each (3 months between 1st and 2nd visit) ]

Enrollment: 50
Actual Study Start Date: August 2005
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEP Procedure: CEP, MEP, TMS
Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • During the previous year, all patients must have experienced or reported at least two of the following symptoms for at least three months and with 25% of bowel movements (when not taking laxatives) (22):1) stool frequency of less than three/week, 2) passage of hard stools, 3) excessive straining, 4) a feeling of incomplete evacuation, 5)sensation of anorectal obstruction or blockage and 6) use of manual maneuvers to facilitate defecations (e.g., digital evacuation).
  • No evidence of structural disease (excluded by colonoscopy/ b. enema and metabolic problem by lab tests.
  • Patients on stable doses of antidepressants without anticholinergic effects will be included.
  • Patient must be undergoing biofeedback treatment
  • Patient must be right-handed

Exclusion Criteria:

  • Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued)
  • Patients with comorbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
  • Neurologic diseases e.g.; head injury.epilepsy,multiple sclerosis, strokes, spinal cord injuries.
  • Impaired cognizance (mini mental score of < 15) and/or legally blind.
  • Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures.
  • Hirschsprung's disease.
  • Alternating constipation and diarrhea (78).
  • Ulcerative and Crohns colitis.
  • Previous pelvic surgery, rectocele repair, bladder repair, radical hysterectomy.
  • Rectal prolapse or anal fissure or anal surgery.
  • Presence of metal in the skull, cranial cavity, back or hips.
  • People who have a cardiac pacemaker, an implanted defibrillator, or a medication pump.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988286


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Augusta University
Investigators
Principal Investigator: Satish Rao, Md, PhD University of Iowa
  More Information

Responsible Party: Satish Rao, Professor, Augusta University
ClinicalTrials.gov Identifier: NCT00988286     History of Changes
Other Study ID Numbers: 5R01DK057100 ( U.S. NIH Grant/Contract )
First Submitted: September 22, 2009
First Posted: October 2, 2009
Last Update Posted: July 13, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Constipation
Hypersensitivity
Signs and Symptoms, Digestive
Signs and Symptoms
Immune System Diseases