Sponsor study identifier
NIH
interventional
50
1 country
1
Study Start
August 2005
Actual (reported)Primary Completion
December 2015
Actual (reported)Study Completion
January 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2005
Actual (reported)September 22, 2009
Actual (reported)October 2, 2009
Actual (reported)December 2015
Actual (reported)January 2016
Actual (reported)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.
2 visits of 3 hours each (3 months between 1st and 2nd visit)
Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Satish Rao, Md, PhD
University of Iowa
50 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2009
First Posted
October 2, 2009
Study Start
August 2005
Actual (reported)Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients
Contact the study team to confirm eligibility.
Primary Completion
December 2015
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
July 13, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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