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Use of High Resolution Colonic Manometry in Studying Motility

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ClinicalTrials.gov Identifier: NCT02574611
Recruitment Status : Unknown
Verified November 2016 by Dr. Mark Korsten, James J. Peters Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : October 14, 2015
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Mark Korsten, James J. Peters Veterans Affairs Medical Center

Brief Summary:
An injury to the spinal cord (SCI) results in numerous medical complications, including gastrointestinal (GI) function. Individuals with SCI may experience severe constipation (prolonged stool retention), incontinence (accidents), and overall difficulty in bowel evacuation. While various treatments and medications have been established to address this complication, there is little knowledge relating to the overall colonic motility. However, new technology such as High Resolution Colonic Manometry allows physicians to visualize high pressure contractions inside the colon, leading to a greater understanding of typical motility, a more accurate diagnosis, and an effective treatment. In this study, the investigators propose to use this technology to understand the effects of SCI on colonic motility by comparing to normal colonic function observed in able-bodied (AB) individuals. In addition, the investigators plan to study the effects of pharmacological treatments, such as neostigmine, on promoting peristaltic contractions in the colon as it is delivered across the skin.

Condition or disease Intervention/treatment Phase
Gastrointestinal Dysfunction Drug: Neostigmine Drug: Glycopyrrolate Other: Saline (Placebo) Device: High Resolution Colonic Manometry Phase 1

Detailed Description:
The investigators data suggests that the fundamental consequence of SCI is a slowing of intestinal peristaltic activity, most likely as a result of down regulation of parasympathetic neural pathways. Furthermore, the investigators have effectively shown that measures involved in increase parasympathetic stimulation results in efficient bowel evacuation and improved bowel care. Such measures include the administration of neostigmine (NEO), which increases peristaltic contractions in the colon, resulting in predictable bowel evacuations. Given the cardiopulmonary side-effects of NEO, an ant-cholinergic known as Glycopyrrolate (GLY) is usually co-administered with NEO to reverse these side effects. However, the investigators knowledge regarding the effects of SCI on colonic motility is still primitive, mainly due to pervious technological disadvantages. New High Resolution Colonic Manometry systems (Medical Measurement Systems Dover, NH) simultaneously capture high amplitude pressure contractions (HAPCs) across the ascending, transverse, descending, and recto-sigmoid colon. Such capabilities allow for a much clearer display of pressure events compared to previous line tracing manometric systems and the direction of contractions are much easier to discern as well. To date, this technology has been an effective tool in diagnosing bowel disorders and complications, such as constipation in able-bodied individuals (AB). However, such studies have not been conducted in a SCI population. This technology also has the potential to capture the effects of NEO+GLY on improving colonic function.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Safety and Efficacy of High Resolution Manometry in Studying Colonic Motility and Iontophoretic Administration of Prokinetic Agents
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: SCI observational
Individuals with SCI will undergo a one day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during a "typical" (eating, sleeping, mobility, etc.)
Device: High Resolution Colonic Manometry
Active Comparator: Able-bodied observational
Able-bodied individuals (non SCI) will undergo a one day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during a "typical" (eating, sleeping, mobility, etc.)
Device: High Resolution Colonic Manometry
Experimental: SCI drug group
Individuals with SCI will undergo a second day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during the transdermal administration of neostigmine and glycopyrrolate
Drug: Neostigmine
Drug: Glycopyrrolate
Device: High Resolution Colonic Manometry
Placebo Comparator: SCI placebo group
Individuals with SCI will undergo a one day observation following elective colonoscopy and placement of the colonic catheter. Investigators will be monitoring colonic motility during the transdermal administration of normal saline solution (placebo)
Other: Saline (Placebo)
Device: High Resolution Colonic Manometry



Primary Outcome Measures :
  1. High Amplitude Contractions [ Time Frame: 1-2days ]
    Monitor changes in High Amplitude Contractions inside the colon during a typical day for SCI and AB patients. The manometry system will record these changes and allow the investigators to visualize changes during various activities (eating, resting, supine, seated, walking, etc.) The investigators will also measure changes in contractions during administration of prokinetic agents to promote bowel evacuations



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic SCI >1year
  • Able-Bodied (non SCI)
  • Undergoing Elective Colonoscopy
  • Age 18-75 years.

Exclusion Criteria:

  • Previous adverse reaction or hypersensitivity to electrical stimulation
  • Known sensitivity to neostigmine or glycopyrrolate
  • Persons with SCI who do not require additional bowel care or have "normal bowel function"
  • Known hypersensitivity to neostigmine or glycopyrrolate
  • History of mechanical obstruction of the intestine or urinary tract
  • History of Myocardial infarction
  • Uncontrollable Hypertension Defined by a blood pressure reading of 160/100 mmHg or higher
  • Organ damage (heart & kidney) and/or transient ischemic attack-cerebral vascular accident as a result of hypertension
  • Known past history of coronary artery disease or bradyarrythmia
  • Active respiratory disease
  • Known history of asthma during lifetime or recent (within 3 months) respiratory infections
  • Adrenal insufficiency
  • Diagnosed coagulopathy
  • Any renal disease or dysfunction
  • Potential for pregnancy
  • Lactating/nursing females
  • Slow-heart beat (HR<45 bpm)
  • Lack of mental capacity to give consent
  • Use of any antibiotic in the past 7 days
  • Use of medications known to affect the respiratory system
  • Use of medications known to alter airway caliber
  • Concurrent participation in other clinical trials (within 30 days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574611


Contacts
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Contact: Mark A Korsten, MD 718-584-9000 ext 6753 mark.korsten@va.gov
Contact: Tradd Cummings, MS 718-584-9000 ext 3107 tradd.cummings@va.gov

Locations
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United States, New York
James J. Peters VA Medical Center Recruiting
Bronx, New York, United States, 10468
Contact: Brian Lyons    718-584-9000 ext 3128    brian.lyons@va.gov   
Contact: Joshua Hobson    718-584-9000 ext 3129    joshua.hobson@va.gov   
Principal Investigator: Mark A. Korsten, MD         
Sub-Investigator: William A. Bauman, MD         
Sub-Investigator: Miroslav Radulovic, MD         
Sub-Investigator: Marinella D. Galea, MD         
Sub-Investigator: Ann M. Spungen, EdD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center

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Responsible Party: Dr. Mark Korsten, Chief Gastroenterologist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02574611     History of Changes
Other Study ID Numbers: KOR-15-026
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Glycopyrrolate
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists