Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT06351995
Eligibility Criteria:
Inclusion Criteria:
* Male or female;
* Age 18 to 89;
* Chronic SCI (\>1 year post injury);
* You have documented constipation/difficulty with bowel evacuation and/or experience pain, straining, or fecal incontinence.
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 as a blood pressure reading of 160/100 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 (heart \& kidney) and/or transient ischemic attack/cerebrovascular accident (TIA-CVA, or stroke) as a result of hypertension;
* Known past history of coronary artery disease or bradyarrhythmia (slow heart rate);
* Symptomatic orthostatic hypotension (low blood pressure with possible dizziness/fainting);
* Deep brain stimulation;
* Pregnancy (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 the study);
* Lactating, nursing females;
* Inability to provide informed consent determined by Montreal Cognitive Assessment Test (MoCA) score of 20 or less. This test is used to detect mild cognitive impairment;
* History of ingrown hair folliculitis (inflammation of hair follicles)
* Concurrent illness (with or without fever), such as lower respiratory illnesses, increased mucous/secretin production, congestive heart failure (CHF), or pneumonia;
* Currently taking the following medications: Bethanechol, Chloroquine, Colistin, Penicillamine, Lithium, Methylcellulose, Trimeprazine, Verapamil, Phenothiazines, Sparfloxacin, Amitriptyline, Doxepin, Imipramine, Potassium chloride, Saquinavir, Dronedarone, Cisapride, Bepridil, Terfenadine, Amiodarone, Ziprasidone, or any medication(s) that could result in adverse reactions with neostigmine and/or glycopyrrolate, as determined by a study physician;
* Currently taking cholinesterase inhibitors, such as those for Parkinson's Disease (PD) or dementia (rivastigmine, donepezil etc.), or medication with anticholinergic activity, such as anti-depressants;
* Myasthenia gravis;
* EKG abnormalities such as bradycardia, prolonged QTc interval, axis shift, bundle branch block, Wolff-Parkinson-White Syndrome (WPW syndrome), 2nd and 3rd degree heart blocks etc. (determined at screening 12-lead EKG);
* Chronic gastrointestinal (GI) 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);
* Fever (as an isolated symptom without "illness"), or who may be exposed to high environmental temperatures
* Concurrent participation in a research study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT06351995
Study Brief:
Protocol Section:
NCT06351995