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NCT00988286 · ClinicalTrials.gov registry record · NA
Mechanism of Action of Biofeedback Therapy
A NA study, sponsored by Augusta University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT00988286 is a NA study that has completed, run by Augusta University. The registered enrollment target is 50 participants.
The verdict
NCT00988286, a NA study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE CEP, MEP, TMS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2005-08 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00988286
The ClinicalTrials.gov registry entry for NCT00988286 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CEP, MEP, TMS is the first listed.
NCT00988286 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00988286 about?
NCT00988286 is a clinical study titled "Mechanism of Action of Biofeedback Therapy". 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 imp...
What is the current status of trial NCT00988286?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2005-08. Estimated completion is 2016-01.
What interventions are being tested in trial NCT00988286?
The interventions under investigation include: CEP, MEP, TMS (PROCEDURE).
Who is sponsoring clinical trial NCT00988286?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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