Mechanism of Action of Biofeedback Therapy

NCT ID: NCT00988286

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Constipation; Hyposensitivity; Hypersensitivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CEP

Group Type: EXPERIMENTAL

CEP, MEP, TMS

Intervention Type: PROCEDURE

Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).

Interventions

CEP, MEP, TMS

Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Satish Rao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Satish Rao, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

5R01DK057100

Identifier Type: NIH

Identifier Source: org_study_id

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