Transdermal Administration by a Novel Wireless Iontophoresis Device

Drug
Bowel health
Online since 3 May 2024, updated 14 days ago

About this trial

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 prob...

Included participants

Gender
All
Age
18 - 89 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    Yes
    C1-S5
    Additionally, participants must
    NOT have a deep brain stimulation device
    NOT have a history of coronary artery disease or bradyarrhythmia

    What’s involved

    Type

    Drug

    Details

    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.

    Potential benefits

    Main benefits

    Bowel health

    Additional benefits

    General health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Mar 2022
    • Organisation
    • James J. Peters Veterans Affairs Medical Center
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Mar 2022
    • Organisation
    • James J. Peters Veterans Affairs Medical Center

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more