Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients

Status unconfirmed

Conditions studied: Healthy Volunteers, Constipation

In brief

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.

Key facts

Study ID

NCT01300897

Run by

Augusta University

People needed

150

Starts

2005-08-01

Expected to finish

2018-12-01

Last updated by the study team

2018-07-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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