Mild electric current may deliver bowel medication through skin, no needles needed

NCT ID NCT02370862

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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