NCT01300897

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. Cortical evoked potentials:A probe with 2 ring electrodes is placed in anus and rectum. A small amount of electrical current is passed. The cortical evoked responses to the anal and rectal electrical stimulation is measured from the scalp using a neurophysiology recorder. 2. Motor evoked potentials: A magnetic coil is placed on the scalp at the anorectal cortical site and discharged using magnetic energy. The anal and rectal motor evoked potentials are then measured using a probe with 2 ring electrodes.

Conditions

• Healthy Volunteers
• Constipation

Interventions

Type	Name	Description
PROCEDURE	Cortical Evoked Potentials	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.
PROCEDURE	Transcranial motor evoked potentials	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.
PROCEDURE	Translumbosacral motor evoked potentials	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.

Timeline

• Start date: 2005-08-01
• Primary completion: 2015-12-01
• Completion: 2018-12-01
• First posted: 2011-02-23
• Last updated: 2018-07-23

Locations

1 site across 1 country: United States