Mechanism of Action of Biofeedback Therapy
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2009 | ||||
| Last Updated Date | March 7, 2011 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00988286 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mechanism of Action of Biofeedback Therapy | ||||
| Official Title ICMJE | Mechanism of Action of Biofeedback Therapy | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: CEP, MEP, TMS
Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS). |
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| Study Arm (s) | Experimental: CEP
Intervention: Procedure: CEP, MEP, TMS |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00988286 | ||||
| Other Study ID Numbers ICMJE | 5R01DK057100 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Satish SC Rao/Professor of Internal Medicine and Director of Neurogastroenterology and GI Motility, University of Iowa | ||||
| Study Sponsor ICMJE | University of Iowa | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Iowa | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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