Spinal Cord Injuries Clinical Trial
Official title:
Pharmacokinetics of Neostigmine and Glycopyrrolate After Intravenous and Transcutaneous Administration by Iontophoresis
A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 2 methods of Iontophoresis (ION): one-patch and two-patch administration, with subsequent blood draws over 1 hour in order to measure the pharmacokinetic behavior of the drugs in-vivo.
The maximum dose of NEO is limited to 10.0 mg and the dose of GLY to 2.0 mg per subject per administration. Subjects will be asked to arrive at the Spinal Cord Research Center at the JJP VAMC (Room 7A-13) on the day of their appointment. On Day 1, following the obtainment the subject's consent, filling out a MoCA cognitive assessment and establishing an IV access point, administration of the medications via IV will be performed. The study design will consist of a Day 1 visit to determine the pharmacokinetic profiles of the IV doses of NEO and GLY. During the second visit, at least 24 hours later, NEO (0.07 mg/kg) and GLY (0.014 mg/kg), applied separately to two patches, will be simultaneously delivered by transdermal administration by ION for 20 minutes. During the third and final visit, at least 24 hours following the second visit, a single patch containing 0.07 mg/kg of NEO and 0.014 mg/kg of GLY will be applied to the skin and delivered by transdermal administration by ION for 20 minutes.. Heart rate, bowel sounds, blood pressure and symptoms will be recorded at 0, 2, 4, 7, 10, 20, 40, 60 minutes of the initiation of the IV push and at 0, 10, 20, 40 and 60 minutes after the initiation of ION. Bowel evacuation time and time after the completion of delivery (by either ION or IV) will be recorded throughout the study visit, as described in Table 2. The subject will assume his/her normal bowel evacuation (BE) position until a bowel movement occurs; privacy draping and privacy will be provided at the time of BE. The subjects will be monitored for a minimum of 60 minutes. A minimum of two research personnel will be present during the study visit to record all of data and perform the tasks required. After the start a 30 second IV push of NEO which will be followed by a NS flush (12 mL), and then a 30 second IV push of GLY which will be followed by a NS flush (12 mL), venous blood (2 mL) will be drawn into a gold-topped vial at 2, 4, 7, 10, 20, 40 and 60 minutes. Identical technique blood draws will be performed at 10, 20, 30, 40 and 60 minutes after the start of ION. Upon drawing, the blood will be placed in an ice bath and spun using a cooled centrifuge within 5 minutes of collection. Upon completion of 5 minutes of centrifugation, the resulting serum will be aliquoted into two separate vials, with equal volumes and labelled with date, time of draw, associated procedure, NEO or GLY testing destination and the subject's unique identifier. The transfer vials will be inserted into dry ice for at least 10 minutes, after which they will be placed into the -80 degrees Celsius freezer. Plasma levels of NEO and of GLY will be batched and measured at a later date. A file designating the tubes with random numbers associated with the draw times will be created for each subject to conceal the sequence of draw and to attempt the removal of possible bias during the measurement and recording of the concentrations of NEO and GLY (SUNY Downstate Albany Research Laboratory using GE LC-MRM detector). Proposed Doses: Day 1: 0.02 mg/kg NEO and 0.004 mg/kg GLY via IV Day 2: 0.07 mg/kg NEO and 0.014 mg/kg GLY via ION (Two patch administration) Day 3: 0.07 mg/kg NEO and 0.014 mg/kg GLY via ION (One patch administration) ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06321172 -
Muscle and Bone Changes After 6 Months of FES Cycling
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05484557 -
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
|
N/A | |
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
Not yet recruiting |
NCT05506657 -
Early Intervention to Promote Return to Work for People With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT04105114 -
Transformation of Paralysis to Stepping
|
Early Phase 1 | |
Recruiting |
NCT03680872 -
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
|
N/A | |
Completed |
NCT04221373 -
Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
|
N/A | |
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Completed |
NCT03898700 -
Coaching for Caregivers of Children With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT04883463 -
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
|
N/A | |
Active, not recruiting |
NCT04881565 -
Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)
|
N/A | |
Completed |
NCT04864262 -
Photovoice for Spinal Cord Injury to Prevent Falls
|
N/A | |
Recruiting |
NCT04007380 -
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
|
N/A | |
Active, not recruiting |
NCT04544761 -
Resilience in Persons Following Spinal Cord Injury
|
||
Terminated |
NCT03170557 -
Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
|
N/A | |
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Recruiting |
NCT04811235 -
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
|
N/A | |
Recruiting |
NCT04736849 -
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
|
N/A |