Use of High Resolution Colonic Manometry in Studying Motility

NCT02574611 | Withdrawn Phase 1

• 1 other identifier: KOR-15-026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• High Amplitude Contractions

  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

  1-2days

Study Arms (4)

SCI observational

EXPERIMENTAL

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" day (eating, sleeping, mobility, etc.).

Device: High Resolution Colonic Manometry

Able-bodied observational

EXPERIMENTAL

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" day (eating, sleeping, mobility, etc.).

Device: High Resolution Colonic Manometry

SCI drug group

ACTIVE COMPARATOR

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

SCI placebo group

PLACEBO COMPARATOR

Individuals with SCI will undergo a second day of 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

Interventions

Neostigmine DRUG

SCI drug group

Glycopyrrolate DRUG

SCI drug group

Saline (Placebo) OTHER

SCI placebo group

High Resolution Colonic Manometry DEVICE

Able-bodied observational; SCI drug group; SCI observational; SCI placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Interventions

Neostigmine; Glycopyrrolate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mark Korsten, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Gastroenterologist

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 14, 2015
• Study Start: October 13, 2015
• Primary Completion: December 25, 2017
• Study Completion: December 25, 2018
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)