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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01300897
Enrollment
150
Registered
2011-02-23
Start date
2005-08-31
Completion date
2018-12-31
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Healthy Volunteers

Keywords

cortical evoked potentials, motor evoked potential responses

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.

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.

Interventions

PROCEDURECortical 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.

PROCEDURETranscranial 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.

PROCEDURETranslumbosacral 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.

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Describe latencies and amplitudes between the brain and gut in healthy volunteers1 visit of 3 hoursMeasurements & 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026