Back to resultsMechanism of Action of Biofeedback Therapy
Primary Purpose
Constipation, Hyposensitivity, Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CEP, MEP, TMS
Sponsored by
About this trial
This is an interventional basic science trial for Constipation
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.
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CEP
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00988286
Brief Title
Mechanism of Action of Biofeedback Therapy
Official Title
Mechanism of Action of Biofeedback Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Hyposensitivity, Hypersensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CEP
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
CEP, MEP, TMS
Intervention Description
Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish Rao, Md, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
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Mechanism of Action of Biofeedback Therapy
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