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Mechanism of Action of Biofeedback Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Georgia Regents University
Sponsor:
Information provided by (Responsible Party):
Satish Rao, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00988286
First received: September 22, 2009
Last updated: September 16, 2014
Last verified: September 2014
  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 Phase
Constipation
Hyposensitivity
Hypersensitivity
Procedure: CEP, MEP, TMS
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Mechanism of Action of Biofeedback Therapy

Resource links provided by NLM:


Further study details as provided by Georgia Regents 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2005
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988286

Contacts
Contact: Satish SC Rao, MD 319-353-6602 satish-rao@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Satish SC Rao, MD    319-353-6602    satish-rao@uiowa.edu   
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Satish Rao, Md, PhD University of Iowa
  More Information

No publications provided

Responsible Party: Satish Rao, Professor, Georgia Regents University
ClinicalTrials.gov Identifier: NCT00988286     History of Changes
Other Study ID Numbers: 5R01DK057100
Study First Received: September 22, 2009
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014