Recruiting
Phase 1

Neostigmine

Sponsor:

James J. Peters Veterans Affairs Medical Center

Code:

NCT02370433

Conditions

Spinal Cord Injury

Neurogenic Bowel

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intravenous Neostigmine and Glycopyrrolate

Transdermal Neostigmine and Glycopyrrolate

Study Details

Brief summary:

Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the investigators have shown that a medication called neostigmine can increase bowel activity and thus, promote bowel movement. The investigators have successfully used this medication with traditional and novel methods of colonoscopic preparations, and have shown that it improves the quality of these preparations. In this study, we would like to test the applicability of this medication to bowel care routines.

The investigators believe that the addition of this medication to the beginning of regular bowel regiments will significantly decrease the time and effort needed to complete BC, thus improving patient perception of their BC routines and quality of life. SCI individuals followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient undergo BC routines assisted by the inpatient care team. BC routines are typically performed every other day, or thrice weekly (Monday, Wednesday, Friday) in "Blue Rooms" located on the inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use of assistive medications or devices, and completeness of bowel care are documented in the patients' electronic medical chart (CPRS) by care providers. The investigators propose to perform the described protocol in individuals who have been admitted to the hospital for routine care and are otherwise healthy. In doing so, the investigators can ensure that patients are vigilantly monitored during each BC session, and that any changes in BC pattern are accurately observed and documented. Furthermore, by performing these procedures on an inpatient basis, study investigators can ensure the consistency of care and daily routine, allowing for better control of study conditions.

Conditions

Spinal Cord Injury

Neurogenic Bowel

Study ID

NCT02370433

Start date

Dec, 2012

Status verified date

Aug, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: 18-75 years
  • Spinal Cord Injury (SCI):
  • greater than 1 year duration
  • excess time for bowel evacuation (> 60minutes per session)

Exclusion Criteria:

  • Previous Adverse Reaction or Hypersensitivity to Electrical Stimulation
  • Do not require additional bowel care or have "normal bowel function"
  • Known sensitivity to Neostigmine and Glycopyrrolate
  • Blockage in Bowel and/or Bladder
  • Myocardial Infarction in the past 6months
  • Blood Pressure ≥160/100 mmHg with/without being on 3 or more different classes of antihypertensive medications
  • Organ Damage (heart \& kidney) and/or transient ischemic attack (TIA)- cerebrovascular accident (CVA) as a result of hypertension
  • Known past history of coronary artery disease, chronic heart failure, bradyarrythmia
  • Slow Heart Rate (<45bpm)
  • Active respiratory diseases
  • Known history of asthma during lifetime
  • Recent (within 3months) respiratory infections
  • Adrenal Insufficiency
  • Pregnancy or potential for pregnancy
  • Lactating/nursing females
  • Use of any antibiotics in past 7days
  • Use of medications known to affect respiratory system
  • Concurrent participation in other clinical trials (within 30days)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bowel Evacuation via IV

The study design will consist of an intravenous (IV) screening visit to determine each individual's response to neostigmine and glycopyrrolate (NG).

experimental: Bowel Evacuation Titration

This design will consist of a dose titration for those subjects who respond positively to IV. These subjects will receive either a low dose and/or a high dose of NG via iontophoresis to determine their responsiveness.

experimental: Bowel Evacuation Iontophoresis

This design will consist of the incorporation of iontophoresis administration into clinical bowel care. The subject will receive the exact dose they responded to during the titration 3x per week for 2weeks.

Interventions

Intravenous Neostigmine and Glycopyrrolate

Transdermal Neostigmine and Glycopyrrolate

Primary outcome measure

  • Biological Response to Study Medication (Changes in BC habits (time to complete BC, reductions/ increases in secondary methods (enemas, suppositories, oral supplements) needed to complete BC will be assessed) [ Time Frame: 24months ]

Central Contacts and Locations

Central contacts

Locations

James J. Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Principal Investigator:

Mark A. Korsten, MD

More Information

Sponsor

James J. Peters Veterans Affairs Medical Center

Last update posted

Aug 29, 2017

Last verified

Aug, 2017

Keywords

  • Spinal Cord Injury
  • Neurogenic Bowel
  • Bowel Evacuation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by James J. Peters Veterans Affairs Medical Center on 2017-08-29.