Investigation of Cortico-Rectal Pathways in Healthy Subjects (Aim 2)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Investigation of Cortico-Rectal Pathways in Healthy Subjects|
- Describe latencies and amplitudes between the brain and gut in healthy volunteers [ Time Frame: 1 visit of 3 hours ] [ Designated as safety issue: No ]
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.
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300897
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Satish SC Rao, MD, PhD||Georgia Regents University|