Healthy VolunteersNCT01300897
Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients
An observational study of Healthy Volunteers and Constipation, run by Augusta University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Constipation
- What is being tested?
- Cortical Evoked Potentials, Transcranial motor evoked potentials and Translumbosacral motor evoked potentials
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 Healthy volunteers. 110 patients with chronic constipation and dyssynergic defecation and rectal hyposensitivity and rectal hypersensitivity
Who may be able to join
- Right-handed adults between ages 18 years and 99 years, who are free of bowel disorders or other medical illnesses.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the detailed description
- 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.
- 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.
- Conditions
- Healthy Volunteers, Constipation
- Being tested
- Cortical Evoked Potentials, Transcranial motor evoked potentials, Translumbosacral motor evoked potentials
- Keywords
- cortical evoked potentials, motor evoked potential responses
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical Evoked PotentialsProcedure or surgery
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 potentialsProcedure or surgery
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 potentialsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Cortical Evoked Potentials; Procedure: Transcranial motor evoked potentials; Procedure: Translumbosacral motor evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 visit of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startAug 2005
- Primary completionDec 2015
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satish Rao, Augusta University
- Investigators
- Satish SC Rao, MD, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300897
- Sponsor's protocol ID
- 5R01DK057100-2
- Other IDs
- 5R01DK057100
- Status last verified
- Jul 2018
- First submitted
- 18 Aug 2010
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients
- ClinicalTrials.gov ID
- NCT01300897
- Acronym / sponsor ID
- 5R01DK057100-2
- Conditions
- Healthy Volunteers, Constipation
- Keywords
- cortical evoked potentials, motor evoked potential responses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Aug 2005 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Procedure: Cortical Evoked Potentials, Procedure: Transcranial motor evoked potentials, Procedure: Translumbosacral motor evoked potentialshealthy volunteers will serve as controls. In each subject the cortical evoked potentials, transcranial motor evoked potentials and translumbosacral motor evoked potentials will be measured. |
| Constipated patients | – | Procedure: Cortical Evoked Potentials, Procedure: Transcranial motor evoked potentials, Procedure: Translumbosacral motor evoked potentialsPatients 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 Healthy volunteers. 110 patients with chronic constipation and dyssynergic defecation and rectal hyposensitivity and rectal hypersensitivity
Key inclusion criteria (1 listed)
- Right-handed adults between ages 18 years and 99 years, who are free of bowel disorders or other medical illnesses.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cortical Evoked PotentialsA 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. | Procedure or surgery | Constipated patients, Healthy Volunteer |
| Transcranial motor evoked potentialsA 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. | Procedure or surgery | Constipated patients, Healthy Volunteer |
| Translumbosacral motor evoked potentialsA 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. | Procedure or surgery | Constipated patients, Healthy Volunteer |
Primary outcome
Describe latencies and amplitudes between the brain and gut in healthy volunteers
Time frame: 1 visit of 3 hours
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satish SC Rao, MD, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Constipation, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe latencies and amplitudes between the brain and gut in healthy volunteers (time frame: 1 visit of 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.