Transdermal Administration by a Novel Wireless Iontophoresis Device

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 bloodpressure reading of 140/100 mmHg or higher with or without taking 3 or more differentclasses of anti-hypertensive medications (drugs used to treat high blood pressure);
• Organ damage or past failure (heart & kidney) and/or transient ischemicattack/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 inits ability to function and causes illness. Heart failure is a condition that may beidentified by the physical findings of peripheral edema (swelling), enlarged liver,fluid around the lungs (pleural effusion), and/or difficulty breathing; the signs ofheart 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 irregularheartbeat, less than 60 beats per minute);
• Symptomatic orthostatic hypotension (low blood pressure with possibledizziness/fainting);
• Deep brain stimulation;
• Pregnancy (men and women who are sexually active and of childbearing potential mustutilize a method of contraception and agree to maintain a contraceptive method untilcompletion 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, isopropylalcohol, or polyethylene glycol;
• Evidence of bradycardia (as defined by a heart rate of less than 60 per minute) or anabnormal electrocardiogram (EKG) at baseline. An EKG measures the heart's electricalsignals and can detect heart problems;
• Currently treated with any cholinesterase inhibitor (e.g., medications for treatmentof Alzheimer's disease, Parkinson's disease, Lewy body dementia, myasthenia gravis) oranti-depressants;
• Concomitant chronic gastrointestinal disease such as inflammatory bowel disease (IBD),irritable bowel syndrome with constipation (IBS-C), or other causes of difficulty withstool evacuation such as hypothyroidism (underactive thyroid);
• Have any of the following conditions: glaucoma, autonomic neuropathy, ulcerativecolitis, prostate hypertrophy, hiatal hernia, hepatic disease (as defined by acute orchronic hepatitis secondary to viral etiology, alcoholism, obesity, autoimmuneconditions, or genetic conditions), concern for incomplete or partial intestinalobstruction, ileostomy, colostomy, cardiac arrythmia, myasthenia gravis, peritonitis;
• Taking any medication that could result in adverse reactions with neostigmine and/orglycopyrrolate, as determined by a study physician; and
• Concurrent participation in a research study.