View Clinical Trial (Medical Research Study)
Mechanism of Action of Biofeedback Therapy
| City: |
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52242 |
| Conditions: |
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Constipation - Hyposensitivity - Hypersensitivity |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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.
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| NCT ID: |
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NCT00988286 |
| Primary Contact: |
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Principal Investigator
Satish Rao, Md, PhD
University of Iowa
Satish SC Rao, MD
Phone: 319-353-6602
Email: satish-rao@uiowa.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Iowa City, Iowa 52242
United States
Satish SC Rao, MD
Phone: 319-353-6602
Email: satish-rao@uiowa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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