This trial is active, not recruiting.

Condition healthy volunteers
Sponsor Georgia Regents University
Start date August 2005
End date March 2014
Trial size 50 participants
Trial identifier NCT01300897, 5R01DK057100-2


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Describe latencies and amplitudes between the brain and gut in healthy volunteers
time frame: 1 visit of 3 hours

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Investigation of Cortico-Rectal Pathways in Healthy Subjects
Principal investigator Satish SC Rao, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Georgia Regents University.