Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT02574611 |
Other study ID # |
KOR-15-026 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
October 13, 2015 |
Est. completion date |
December 25, 2018 |
Study information
Verified date |
September 2021 |
Source |
James J. Peters Veterans Affairs Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.