NCT01300897|Unknown
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Sponsor study identifier
Secondary identifiers
NIH
observational
150
1 country
1
Study Start
August 2005
Actual (reported)Primary Completion
December 2015
Actual (reported)Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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. However, in order to better understand these mechanisms in patients, the investigators need to examine and establish normative data and compare findings with healthy subjects. The investigators specific aims are to examine and evaluate the following 40 normal subjects; (1) To evaluate the afferent cortical evoked potentials in response to the electrical stimulation of the anorectum and (2) To evaluate the corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses following noninvasive lumbosacral and transcranial magnetic stimulation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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)August 18, 2010
Actual (reported)February 23, 2011
Actual (reported)December 2015
Actual (reported)December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Describe latencies and amplitudes between the brain and gut in healthy volunteers
Measurements \& Analysis: The latency, inter-peak latency and amplitude of each component of the cortical evoked potentials will be averaged to obtain group mean data. Statistical Analysis: The paired t-test or Wilcoxon signed-rank test will be used to compare the latencies. Lumbosacral and Transcranial Magnetic Stimulation (TMS) Data and Statistical Analysis: Mean latency and mean amplitude for each individual will be calculated.
1 visit of 3 hours
healthy volunteers will serve as controls. In each subject the cortical evoked potentials, transcranial motor evoked potentials and translumbosacral motor evoked potentials will be measured.
Patients with chronic constipation and rectal hypersensitivity or hyposensitivity and/or dyssynergic defecation.In each subject the cortical evoked potentials, transcranial motor evoked potentials and translumbosacral motor evoked potential will be measured
A probe with 2 ring electrodes is placed in the anorectum. A small amount of electric current is passed separately through the anal and rectal electrodes.. The cortical evoked potentials from the anal and rectal sites are measured.
A probe with 2 ring electrodes is placed in the anorectum. A magnetic coil is placed on the scalp at the anorectal site on each side, and discharged using magnetic energy. The motor evoked potentials at the anal and rectal sites are measured.
40 Healthy volunteers. 110 patients with chronic constipation and dyssynergic defecation and rectal hyposensitivity and rectal hypersensitivity
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Satish SC Rao, MD, PhD
Augusta University
First Submitted
August 18, 2010
First Posted
February 23, 2011
Study Start
August 2005
Actual (reported)Primary Completion
December 2015
Actual (reported)Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
A probe with 2 ring electrodes is placed in the anorectum. A magnetic coil is placed on the back at the lumbar plexus and sacral plexus levels and discharged using magnetic energy. The motor evoked potentials at the anal and rectal sites are measured.
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Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 23, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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