NCT00988286

Mechanism of Action of Biofeedback Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 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. The investigators' specific aims are; (1) To evaluate the afferent cortical evoked potentials in response to the electrical stimulation of the anorectum (i) before and after biofeedback therapy and (ii) compare responders with nonresponders. (2) To evaluate the corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses following noninvasive lumbosacral and transcranial magnetic stimulation (i) before and after biofeedback therapy and (ii) compare responders with nonresponders. The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication and alters cortical and neuromuscular function. The investigators' specific aims are to evaluate 60 patients with dyssynergia (i) before and after biofeedback therapy and (ii) compare responders with nonresponders by examining: (A) The afferent cortical evoked potentials using electrical stimulation of the anus and rectum. (B) The efferent cortical evoked potentials by lumbosacral and transcranial magnetic stimulation and recording the anal and rectal electromyographic responses.

Conditions

• Constipation
• Hyposensitivity
• Hypersensitivity

Interventions

Type	Name	Description
PROCEDURE	CEP, MEP, TMS	Patients and healthy volunteers will undergo cortical evoked potentials (CEP), motor evoked potentials (MEP) and transcranial evoked potentials (TMS).

Timeline

• Start date: 2005-08-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2009-10-02
• Last updated: 2017-07-13

Locations

1 site across 1 country: United States