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

NCT01300897 | Unknown

• 2 other identifiers: 5R01DK057100-25R01DK057100
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Constipation

Keywords

cortical evoked potentials, motor evoked potential responses

Outcome Measures

Primary Outcomes (1)

• Describe latencies and amplitudes between the brain and gut in healthy volunteers

  Measurements \& Analysis: The latency, inter-peak latency and amplitude of each component of the cortical evoked potentials will be averaged to obtain group mean data. Statistical Analysis: The paired t-test or Wilcoxon signed-rank test will be used to compare the latencies. Lumbosacral and Transcranial Magnetic Stimulation (TMS) Data and Statistical Analysis: Mean latency and mean amplitude for each individual will be calculated.

  1 visit of 3 hours

Study Arms (2)

Healthy Volunteer

healthy volunteers will serve as controls. In each subject the cortical evoked potentials, transcranial motor evoked potentials and translumbosacral motor evoked potentials will be measured.

Procedure: Cortical Evoked Potentials; Procedure: Transcranial motor evoked potentials; Procedure: Translumbosacral motor evoked potentials

Constipated patients

Patients with chronic constipation and rectal hypersensitivity or hyposensitivity and/or dyssynergic defecation.In each subject the cortical evoked potentials, transcranial motor evoked potentials and translumbosacral motor evoked potential will be measured

Procedure: Cortical Evoked Potentials; Procedure: Transcranial motor evoked potentials; Procedure: Translumbosacral motor evoked potentials

Interventions

Cortical Evoked Potentials PROCEDURE

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.

Constipated patients; Healthy Volunteer

Transcranial motor evoked potentials PROCEDURE

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.

Constipated patients; Healthy Volunteer

Translumbosacral motor evoked potentials PROCEDURE

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.

Constipated patients; Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

40 Healthy volunteers. 110 patients with chronic constipation and dyssynergic defecation and rectal hyposensitivity and rectal hypersensitivity

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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Satish SC Rao, MD, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: February 23, 2011
• Study Start: August 1, 2005
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

US (1)