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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01300897
• Other study ID #: 5R01DK057100-2
• Secondary ID: 5R01DK057100
• Status: Active, not recruiting
• Start date: August 2005
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Constipation
• Healthy Volunteers

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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