Use of High Resolution Colonic Manometry in Studying Motility

• Status: Withdrawn
• Trial end date: 2018-12-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Treatments: Glycopyrrolate; Neostigmine

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)