Spinal Cord InjuriesEarly Phase 1NCT06351852
Transdermal Administration by a Novel Wireless Iontophoresis Device
A Early Phase 1 study testing Combination of Neostigmine and Glycopyrrolate and I-Box by Dynatronics in people with Spinal Cord Injuries and Constipation, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Constipation, Fecal Incontinence
- What is being tested?
- Combination of Neostigmine and Glycopyrrolate and I-Box by Dynatronics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 24 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18-89 years
- Able-bodied
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
About this study
Official title: Safety and Pharmacokinetics of Positively Charged Compounds by Transdermal Administration by a Novel Wireless Iontophoresis Device
Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE).
The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis).
The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation.
Read the detailed description
Subject recruitment will be drawn from prior participants in our Centers' research studies and the outpatient clinics. Subjects will be informed verbally and in writing of the purpose of this study. Informed consent will be obtained from all subjects who agree to participate. Subjects will be free to withdraw their consent at any time. Subject travel costs and a stipend for participation will be provided by the grant (DOD CDMRP: SC180166). Records will be kept confidential by removing the name of the subject from all data and assigning each subject a random identification number which will be recorded on all subject data sheets and linked by identifiers which are listed in a master key that is appropriately secured. An investigator or research coordinator will enroll subjects, coordinate blood laboratory studies, collect data, and coordinate the responsibilities of all study subjects. Subjects will be asked to arrive at the Center at the JJP VAMC (Room 7A-13) on the day of their appointment. A baseline EKG will be obtained to exclude participants with any EKG abnormalities. On Day 1, after obtaining subject consent, vitamin B12 will be administered transcutaneously via the wireless ION device. On Day 2, NEO (0.07 mg/kg) and GLY (0.014 mg/kg) will be administered transcutaneously via wired ION device (Dynatron iBox). On Day 3, NEO (0.07 mg/kg) and GLY (0.014 mg/kg) will be administered transcutaneously by a wireless ION device. The maximum dose of neostigmine is 10 mg or 0.07 mg/kg (whichever is less), and the maximum dose of glycopyrrolate is 2 mg or 0.014 mg/kg. All safety end points will also be collected on each day of the study.
After NEO and GLY administration, heart rate, bowel sounds, blood pressure, oxygen levels and any adverse symptoms will be recorded at times of each blood collection. Bowel sounds and evacuation time will also be recorded, if each occurs, but they are not endpoints of this protocol. The subjects will be monitored for a minimum of 120 minutes. At least two research personnel will be present during the study visit to record all data and perform the tasks required.
After the administration of each agent(s), venous blood (4 ml) will be collected into a purple-top tube (EDTA tube) at baseline, 5, 10, 20, 30, 40 60, 90, and 120 minutes. The blood will be placed in an ice bath and centrifuged to separate the formed blood cell elements from plasma. The plasma will be aliquoted in equal volume into two vials and labelled with the date, protocol number, and the subject's unique identifier and timepoint of sample collection. The samples will be placed in a -80 degrees Celsius freezer until batch shipped for assay of NEO and of GLY by mass spectroscopy in the SUNY Downstate Albany Research Laboratory by Dr. Qishan Lin.
- Being tested
- Combination of Neostigmine and Glycopyrrolate, I-Box by Dynatronics
- Keywords
- Neostigmine, Glycopyrrolate, Pharmacokinetic, Constipation, Bowel Control, Mass Spectroscopy, Stool Incontinence, Transdermal
- Medical subject headings
- Spinal Cord Injuries, Constipation, Fecal Incontinence, Neurogenic Bowel, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Neostigmine and GlycopyrrolateDrug
Transcutaneous
I-Box by DynatronicsDevice
Also called Iontophoresis
Electric field conducting drugs through the skin without compromising its integrity
| Study group | Role | What they receive |
|---|---|---|
| Primary | Experimental | 6 subjects will receive 2 medications transdermally. Receives: Drug: Combination of Neostigmine and Glycopyrrolate; Device: I-Box by Dynatronics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of bowel evacuation
Presence or absence of bowel evacuation post Neostigmine and Glycopyrrolate administration
Measured: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Time to bowel evacuation
Time to bowel evacuation post Neostigmine and Glycopyrrolate administration
Measured: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Stool Consistency
Stool Consistency (Bristol stool scale) post bowel evacuation
Measured: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Stool Quantity
Stool quantity (by weight) post bowel evacuation
Measured: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Secondary outcomes (1)
Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps
The presence/number of cholinergic and anti-cholinergic side-effects on a standardized point scale will be determined, as well as their severity (e.g., mild, moderate, or severe).
Measured: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start22 Mar 2022
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Chris Cardozo, James J. Peters Veterans Affairs Medical Center
- Investigators
- Christopher P Cardozo, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351852
- Sponsor's protocol ID
- 1678243
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Positively Charged Compounds by Transdermal Administration by a Novel Wireless Iontophoresis Device
- ClinicalTrials.gov ID
- NCT06351852
- Acronym / sponsor ID
- 1678243
- Keywords
- Neostigmine, Glycopyrrolate, Pharmacokinetic, Constipation, Bowel Control, Mass Spectroscopy, Stool Incontinence, Transdermal
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE).
The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis).
The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation.
Detailed description
Subject recruitment will be drawn from prior participants in our Centers' research studies and the outpatient clinics. Subjects will be informed verbally and in writing of the purpose of this study. Informed consent will be obtained from all subjects who agree to participate. Subjects will be free to withdraw their consent at any time. Subject travel costs and a stipend for participation will be provided by the grant (DOD CDMRP: SC180166). Records will be kept confidential by removing the name of the subject from all data and assigning each subject a random identification number which will be recorded on all subject data sheets and linked by identifiers which are listed in a master key that is appropriately secured. An investigator or research coordinator will enroll subjects, coordinate blood laboratory studies, collect data, and coordinate the responsibilities of all study subjects. Subjects will be asked to arrive at the Center at the JJP VAMC (Room 7A-13) on the day of their appointment. A baseline EKG will be obtained to exclude participants with any EKG abnormalities. On Day 1, after obtaining subject consent, vitamin B12 will be administered transcutaneously via the wireless ION device. On Day 2, NEO (0.07 mg/kg) and GLY (0.014 mg/kg) will be administered transcutaneously via wired ION device (Dynatron iBox). On Day 3, NEO (0.07 mg/kg) and GLY (0.014 mg/kg) will be administered transcutaneously by a wireless ION device. The maximum dose of neostigmine is 10 mg or 0.07 mg/kg (whichever is less), and the maximum dose of glycopyrrolate is 2 mg or 0.014 mg/kg. All safety end points will also be collected on each day of the study.
After NEO and GLY administration, heart rate, bowel sounds, blood pressure, oxygen levels and any adverse symptoms will be recorded at times of each blood collection. Bowel sounds and evacuation time will also be recorded, if each occurs, but they are not endpoints of this protocol. The subjects will be monitored for a minimum of 120 minutes. At least two research personnel will be present during the study visit to record all data and perform the tasks required.
After the administration of each agent(s), venous blood (4 ml) will be collected into a purple-top tube (EDTA tube) at baseline, 5, 10, 20, 30, 40 60, 90, and 120 minutes. The blood will be placed in an ice bath and centrifuged to separate the formed blood cell elements from plasma. The plasma will be aliquoted in equal volume into two vials and labelled with the date, protocol number, and the subject's unique identifier and timepoint of sample collection. The samples will be placed in a -80 degrees Celsius freezer until batch shipped for assay of NEO and of GLY by mass spectroscopy in the SUNY Downstate Albany Research Laboratory by Dr. Qishan Lin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | Experimental | Drug: Combination of Neostigmine and Glycopyrrolate, Device: I-Box by Dynatronics6 subjects will receive 2 medications transdermally. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female
- Age 18-89 years
- Able-bodied
Key exclusion criteria (20 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of Neostigmine and GlycopyrrolateTranscutaneous | Drug | Primary |
| I-Box by DynatronicsAlso: IontophoresisElectric field conducting drugs through the skin without compromising its integrity | Device | Primary |
Primary outcome
Presence or absence of bowel evacuation
Time frame: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Presence or absence of bowel evacuation post Neostigmine and Glycopyrrolate administration
Time to bowel evacuation
Time frame: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Time to bowel evacuation post Neostigmine and Glycopyrrolate administration
Stool Consistency
Time frame: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Stool Consistency (Bristol stool scale) post bowel evacuation
Stool Quantity
Time frame: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Stool quantity (by weight) post bowel evacuation
1 secondary outcome
Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps
Time frame: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher P Cardozo, MD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Combination of Neostigmine and Glycopyrrolate and I-Box by Dynatronics in people with Spinal Cord Injuries and Constipation, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of bowel evacuation (time frame: Up to 2 hours post Neostigmine and Glycopyrrolate administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.