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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
September 22, 2009
October 2, 2009
July 13, 2017
August 2005
December 2015   (Final data collection date for primary outcome measure)
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) ]
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: Trial entry and after completion of biofeedback study (3 months) ]
Complete list of historical versions of study NCT00988286 on ClinicalTrials.gov Archive Site
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Mechanism of Action of Biofeedback Therapy
Mechanism of Action of Biofeedback Therapy

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.

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Interventional
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Constipation
  • Hyposensitivity
  • Hypersensitivity
Procedure: CEP, MEP, TMS
Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).
Experimental: CEP
Intervention: Procedure: CEP, MEP, TMS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2016
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00988286
5R01DK057100( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Satish Rao, Augusta University
Augusta University
Not Provided
Principal Investigator: Satish Rao, Md, PhD University of Iowa
Augusta University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP