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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

September 22, 2009
September 16, 2014
August 2005
December 2014   (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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
50
January 2015
December 2014   (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.
Both
18 Years and older
Yes
Contact: Satish SC Rao, MD 319-353-6602 satish-rao@uiowa.edu
United States
 
NCT00988286
5R01DK057100
No
Satish Rao, Georgia Regents University
Georgia Regents University
Not Provided
Principal Investigator: Satish Rao, Md, PhD University of Iowa
Georgia Regents University
September 2014

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