Mild electric current may deliver bowel medication through skin, no needles needed
NCT ID NCT02370862
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This early-phase study tests whether a combination of two medications (neostigmine and glycopyrrolate) can be delivered through the skin using a mild electric current to help people with spinal cord injury have a bowel movement. Participants first receive the medication intravenously to see how they respond, then test different doses via a skin patch. The goal is to find a needle-free way to speed up bowel care, which often takes over an hour for many with spinal cord injury.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- neostigmine and glycopyrrolate delivered through the skin via iontophoresis
- What this could lead to
- If effective, this needle-free method could allow people with spinal cord injury to manage bowel care at home more quickly and easily.
- What could go wrong
- This is a very early, small pilot study. The skin-delivery method may not work as well as the intravenous version, and side effects like changes in heart rate or breathing are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
28 people
The number who actually took part.
- Start date
-
Feb 2013
- Finished
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Dec 2016
- Lead sponsor
-
A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Incomplete or complete SCI, * Tetraplegia or paraplegia, * Excess time for bowel evacuation (\> 60 minutes per bowel training session) Exclusion Criteria: * Previous adverse reaction or hypersensitivity to electrical stimulation, * Known sensitivity to neostigmine or glycopyrrolate, * Do not require additional bowel care or have "normal bowel function", * Blockage Bowel or Bladder, * Myocardial infarction in the past 6 months, * Blood pressure of 160/100mmHg or higher with or without being on 3 or more different classes of anti-hypertensive medications * Organ damage (heart \& kidney damage) and/or transient ischemic attack (TIA)- cerebrovascular accident (CVA) 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, * Pregnancy or potential for pregnancy, * Lactating/nursing females, * Slow heart rate (\<45 bpm) * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
James J. Peters VA Medical Center
The Bronx, New York, 10468, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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