No-Needle patch could help spinal injury patients poop
NCT ID NCT06351852
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early study tested a wireless patch that uses a tiny electric current to push two drugs (neostigmine and glycopyrrolate) through the skin and into the blood. The goal is to help people with spinal cord injury have predictable bowel movements without needles. Only 2 healthy volunteers took part, and the study focused on safety and how the drugs enter the body.
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
- What this could lead to
- If it works, this could lead to a needle-free way for people with spinal cord injury to manage bowel problems at home.
- What could go wrong
- This is a very early, tiny study in just 2 healthy people. It only checks safety and drug levels, not whether it actually works for bowel problems.
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
-
2 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
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Sep 2024
- Lead sponsor
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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 89 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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: * Male or female * Age 18-89 years * Able-bodied Exclusion Criteria: * Previous adverse reaction or hypersensitivity to electrical stimulation; * Known sensitivity (prior reaction or allergy) to neostigmine or glycopyrrolate; * History of mechanical obstruction (physical blockage) of the GI or urinary tract (e.g., due to scar tissues forming after surgery, gallstones); * Myocardial infarction (heart attack) within 6 months of trial; * Malignant and/or uncontrollable hypertension (high blood pressure) defined by a blood pressure reading of 140/100 mmHg or higher with or without taking 3 or more different classes of anti-hypertensive medications (drugs used to treat high blood pressure); * Organ damage or past failure (heart \& kidney) and/or transient ischemic attack/cerebrovascular accident (TIA-CVA, or stroke) as a result of hypertension. Organ damage may be defined as impairment to any major body part/organ that results in its ability to function and causes illness. Heart failure is a condition that may be identified by the physical findings of peripheral edema (swelling), enlarged liver, fluid around the lungs (pleural effusion), and/or difficulty breathing; the signs of heart failure may be usually identified by documenting a reduced cardiac output. Kidney failure is diagnosed by a severe reduction in glomerular filtration rate, usually \<30 ml/min. End stage renal failure results in fluid accumulation/edema, cardiac friction rubs, and symptoms of azotemia (generally feeling sick); * Known past history of coronary artery disease or bradyarrhythmia (slow irregular heartbeat, less than 60 beats per minute); * Symptomatic orthostatic hypotension (low blood pressure with possible dizziness/fainting); * Deep brain stimulation; * Pregnancy (men and women who are sexually active and of childbearing potential must utilize a method of contraception and agree to maintain a contraceptive method until completion of study); * Lactating, nursing females; * Inability to provide informed consent signaled by Montreal Cognitive Assessment Test (MoCA) score of 20 or less. This test is used to detect mild cognitive impairment; * Concurrent illness and fever; * Allergy to sodium lauryl sulfate, silver chloride, agarose gel, citric acid, isopropyl alcohol, or polyethylene glycol; * Evidence of bradycardia (as defined by a heart rate of less than 60 per minute) or an abnormal electrocardiogram (EKG) at baseline. An EKG measures the heart's electrical signals and can detect heart problems; * Currently treated with any cholinesterase inhibitor (e.g., medications for treatment of Alzheimer's disease, Parkinson's disease, Lewy body dementia, myasthenia gravis) or anti-depressants; * Concomitant chronic gastrointestinal disease such as inflammatory bowel disease (IBD), irritable bowel syndrome with constipation (IBS-C), or other causes of difficulty with stool evacuation such as hypothyroidism (underactive thyroid); * Have any of the following conditions: glaucoma, autonomic neuropathy, ulcerative colitis, prostate hypertrophy, hiatal hernia, hepatic disease (as defined by acute or chronic hepatitis secondary to viral etiology, alcoholism, obesity, autoimmune conditions, or genetic conditions), concern for incomplete or partial intestinal obstruction, ileostomy, colostomy, cardiac arrythmia, myasthenia gravis, peritonitis; * Taking any medication that could result in adverse reactions with neostigmine and/or glycopyrrolate, as determined by a study physician; and * Concurrent participation in a research study.
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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
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James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Serotonin precursor probed for spinal cord injury effects
- Can exercise boost the power of abdominal massage for constipation?
- Breathing brief Low-Oxygen bursts may boost sleep apnea treatment
- Which bowel care tool wins the race? trial pits suppository, enema, and irrigation device
- Pure oxygen tested as a switch for dormant nerves after spinal cord injury
- Spinal stimulation tested to help kids with spinal cord injuries sit taller