Wireless device for delivering medication to improve bowel function in spinal cord injury patients

Safety and Pharmacokinetics of Positively Charged Compounds by Transdermal Administration by a Novel Wireless Iontophoresis Device

This study is testing a new wireless device that delivers medication to help people with spinal cord injuries improve their bowel function.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: James J. Peters Veterans Affairs Medical Center (Federal)
• Locations: 1 site (Bronx, New York)
• Trial ID: NCT06351852 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a novel approach to treat bowel dysfunction in individuals with spinal cord injuries using a wireless iontophoresis device to administer a combination of neostigmine and glycopyrrolate. The study aims to evaluate the safety and effectiveness of this transdermal delivery method in promoting bowel evacuation. Participants will receive the medications over a series of days, with careful monitoring and data collection to assess outcomes. The trial will also ensure participant confidentiality and provide stipends for involvement.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-89 with spinal cord injuries experiencing neurogenic bowel disorders.

Not a fit: Patients with known sensitivities to the study medications or those with recent heart issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve bowel control and quality of life for patients with spinal cord injuries.

How similar studies have performed: While the approach of using transdermal drug delivery is innovative, similar studies have shown promise in treating bowel dysfunction, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Bronx, New York

• James J. Peters Veterans Affairs Medical Center — Bronx, New York, United States (Recruiting)

Study contacts

• Principal investigator: Christopher P Cardozo, MD — James J. Peters Veterans Affairs Medical Center
• Study coordinator: Christopher P Cardozo, MD

Conditions Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel; Neostigmine; Glycopyrrolate; Pharmacokinetic; Bowel Control