Gastrointestinal Research

Investigator: Mark Korsten, MD

Having a SCI frequently results in difficulty with bowel evacuation. Our investigators are testing a dual medication combination whose novel delivery is being tested through the skin (e.g., transdermally via iontophoresis) to improve routine bowel care. How exoskeletal-mediated ambulation alters colonic motility is also being assessed using high resolution manometry methodology.


Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals with SCI

Part A:  Screening-1visit
A SCI ASIA Impairment examination will be performed to assess level of injury and motor/sensory functions. Following this exam, all subjects will undergo an Anorectal Manometry to assess the strength and control of each subject’s squeeze and bear down maneuvers. In addition to this assessment, each subject will be asked to answer surveys regarding their satisfaction with their bowel program and bowel function.

Part B:  Biofeedback Training – 13 visits total.
Subject will arrive at the SCI damage research center 2x/week for 6 weeks for biofeedback training to strengthen the anorectal sphincter muscles, which control bowel movements. After training is complete, a 2nd Anorectal manometry will be performed to assess the progress of the training as well as the same questionnaires in Part A.

Part C: At Home Exercises:
Subject will be home exercises to complete for 6 weeks total.

Part D:  Final Assessment-1visit
Subject will perform a 3rd Anorectal Manometry to assess progress of 12 weeks of training. Subjects will also complete questionnaires.

Inclusion Criteria:  Chronic SCI (more than 1 year); Able-bodied (non-SCI); Ages 18-75 years old.
Time Commitment: 15 visits, each 15 minutes, over the course of 12 weeks
Reimbursement:  Able-bodied get $100 for Part 1 of the study only.  Total reimbursement for SCI subjects who completed the study in its entirety is $500: Each Anorectal Manometry is $50 (3 manometries total); each Biofeedback session is $25 (12 sessions total); $50 for the 6 week of home exercise.


A Novel Application of Iontophoresis in the Transcutaneous Delivery of a Prokinetic Agent for the Promotion of Bowel Evacuation

Visit 1: Intravenous (IV) Screening
Subject will receive medication known to initiate a bowel evacuation. Neostigmine + Glycopyrrolate will be administered via IV and monitored for 60minutes. Blood Pressure, Heart Rate, Oxygenation, Bowel Evacuation and Sign and Symptoms will be measured throughout the study Airway resistance will be measured pre- and post-study.

Visit 2: Low Dose
If a subject has a bowel evacuation in Visit 1 they will continue to Visit 2. Subjects will receive the same medication with the exception that it will be administered through the skin via iontophoresis.

Visit 3: High Dose
If the subject has a bowel evacuation in visit 2 they will continue to Visit 3 where they will receive a higher dose via iontophoresis.

Inclusion Criteria:  Incomplete or complete SCI. Tetraplegia or paraplegia. Excess time for bowel evacuation ( >60 minutes per bowel training session). Age 18-75.
Time Commitment: 3 visits. Each visit is 2 hours long.
Reimbursement: $100 per visit.


Effects of the Addition of a Prokinetic Agent to thrice weekly Bowel Care during Inpatient Hospital Stays

Visit 1: IV Screening
 An IV line will be placed in and subject will receive IV dose of Neostigmine + Glycopyrrolate. Airway resistance will be measured pre- and post-study. Blood Pressure, Heart Rate, Bowel Evacuation and Sign and Symptoms will be measured throughout the study

Visit 2:  Baseline
Subject will be monitored for one week and answer questionnaires. An abdominal flatbed X-Ray will be taken at the beginning and at the end of the week and weight.

Visit 3: Low Dose
If a subject has a bowel evacuation in Visit 1 they will continue to Visit 2. Subjects will receive the same medication with the exception that it will be administered through the skin via iontophoresis

Visit 4: High Dose
If a subject does not have bowel evacuation in Visit 3 they will continue to Visit 4. Subjects will receive the same medication with the exception that it will be a higher dose.

Visit 5:  Inpatient Bowel Care
If subjects have a bowel evacuation during visits 3-4, they will receive the same dose 3/ week for 2 weeks total via iontophoresis. The study will be carried out same as on their previous visit.  2 Abdominal Flatbed X-Rays will be taken and questionnaires will be administered.

Inclusion Criteria:  Incomplete or complete SCI. Tetraplegia or paraplegia. Excess time for bowel evacuation ( >60 minutes per bowel training session). Age 18-75.
Time Commitment: 4 weeks
Reimbursement: $75 for Visit 1.  $50 for Visit 2.  $75 per Visit 3 and 4.  $75/week for Visit 5. Total received on completion of the study will be $475.


Safety and Efficacy of High Resolution Manometry in Studying Colonic Motility and Iontophoretic Administration of Prokinetic Agents

Visit 1: IV Screening
Subject will receive medication known to initiate a bowel evacuation. Neostigmine + Glycopyrrolate will be administered via IV and monitored for 60minutes. Blood Pressure, Heart Rate, Oxygenation, Bowel Evacuation and Sign and Symptoms will be measured throughout the study Airway resistance will be measured pre- and post-study An ECG will be performed before and after.

Visit 2:  Colonoscopy/Catheter Placement
If there is a positive response to Visit 1 subject will be given a complete bowel preparation to cleanse the colon. Subject will then undergo routine clinical colonoscopy with addition of insertion of colonic catheter, which will record pressure changes inside the colon for approximately 48hrs. Subjects will remain as inpatient for 1-2 day following colonoscopy procedure

Visit 3: Manometry Recording/Bowel Evacuation
During the inpatient stay, subjects’ bowel motility will be monitored via the colonic catheter. Normal diets, exercise, sleep, and activity and their effects on the bowel will be recorded. In addition, subjects will receive Neostigmine+Glycopyrrolate via iontophoresis in order to initiate a bowel evacuation. During this period, the catheter will record pressure changes

Inclusion Criteria:  Chronic SCI >1 year; Able-Bodied(non SCI); Undergoing Elective Colonoscopy. Age 18-75.
Time Commitment: 3 days
Reimbursement: Visit 1 is $100 for SCI only. Recording Sessions/Inpatient Stay: $300 for SCI and Able-Bodied.


Comparison of GERD and the Effects of Anti-Reflux Therapy on Pulmonary Function between Able-Bodied and SCI Individuals

Visit 1: GERD and Pulmonary Screening
Subjects will undergo 24hours of esophageal pH monitoring to measure changes in pH (acid) being released from the stomach into the esophagus. In addition to this, a full pulmonary function test (body plethysmography, spirometry, impulse oscillimetry), additional biomarkers (exhale breath concentrate, fractional exhaled nitric oxide), and surveys will be administered to assess lung function and its relationship to GERD.

Visit 2: GERD Interpretation
Subjects that test positive for GERD will undergo 8weeks of treatment using a protein pump inhibitor (PPI) which will reduce acidity in the stomach. Subjects will perform daily spirometry measurements using a portable device for 8weeks.

Visit 3-4: GERD and Pulmonary Follow-Up
Subjects will repeat all procedures and assessments described in visit 1.

Inclusion Criteria:  Subjects with Tetraplegia (Level of SCI C4-8); High Paraplegia (Level of SCI T1-T7); Low Paraplegia (Level of SCI T8 or below); Able-Bodied Subjects (non SCI); Duration of injury ≥ 1 year; age 18-75 years
Time Commitment: 9weeks
Reimbursement: Visits 1-2 is $150. Visits 3-4 is $150

Studies Underway

Search

Contact Us

Brian Lyons, BA
Research Coordinator
(718) 584-9000 ext. 3128
Brian.Lyons@va.gov

Sandeep Kahal, MBBS
Research Assistant
(718) 584-9000 ext. 3107
sandeep.kahal@va.gov

Recent Publications

  1. Korsten MA, Spungen AM, Radulovic M, Rosman AS, Hunt K, Galea MD, Kornfeld SD, Lyons BL, Yen C, Bauman WA. Neostigmine Administered With MoviPrep Improves Bowel Preparation for Elective Colonoscopy in Patients With Spinal Cord Injury: A Randomized Study. J Clin Gastroenterol. 2015 Oct;49(9):751-6. PMID:25599220

http://www.ncbi.nlm.nih.gov/pubmed/25599220

  1. Lyons BL, Korsten MA, Spungen AM, Radulovic M, Rosman AS, Hunt K, Galea MD, Kornfeld SD, Yen C, Bauman WA. Comparison between pulsed irrigation enhanced evacuation and polyethylene glycol-electrolyte lavage solution for bowel preparation prior to elective colonoscopy in veterans with spinal cord injury. J Spinal Cord Med. 2014 Aug 6. [Epub ahead of print] PMID:25096918

http://www.ncbi.nlm.nih.gov/pubmed/25096918