Investigation of Cortico-Rectal Pathways in Healthy Subjects (Aim 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01300897
Recruitment Status : Unknown
Verified January 2014 by Satish Rao, Augusta University.
Recruitment status was:  Active, not recruiting
First Posted : February 23, 2011
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):
Satish Rao, Augusta University

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. 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.

Condition or disease
Healthy Volunteers

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Cortico-Rectal Pathways in Healthy Subjects
Study Start Date : August 2005
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Healthy Volunteer

Primary Outcome Measures :
  1. Describe latencies and amplitudes between the brain and gut in healthy volunteers [ Time Frame: 1 visit of 3 hours ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
40 Healthy volunteers.

Inclusion criteria:

  • Right-handed adults between ages 18 years and 99 years, who are free of bowel disorders or other medical illnesses.

Exclusion Criteria:

  • Potential subjects 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.
  • People who have metal in their skull or under the skull, or have metal in the back or hips.
  • People who have a cardiac pacemaker, implanted defibrillator or medication pump.
  • 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.
  • Previous pelvic surgery, rectocele repair, bladder repair, radical hysterectomy.
  • Rectal prolapse or anal fissure or anal surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01300897

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Augusta University
Principal Investigator: Satish SC Rao, MD, PhD Augusta University

Responsible Party: Satish Rao, Professor, Augusta University Identifier: NCT01300897     History of Changes
Other Study ID Numbers: 5R01DK057100-2
5R01DK057100 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Satish Rao, Augusta University:
cortical function, motor evoked potential responses