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No reportable findings are possible. The PI/Co-PI were unable to recruit participants for this study. One participant was consented but did not undergo any study procedure.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.). |
|
| 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.). |
|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neostigmine | Drug |
| ||
| Glycopyrrolate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Korsten, MD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center | The Bronx | New York | 10468 | United States |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| Saline (Placebo) | Other |
|
| High Resolution Colonic Manometry | Device |
|
| D009861 |
| Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |