Pupillometry and Locus Coeruleus Activation (PuLCA)

Sponsor
University of Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04579653
Collaborator
(none)
34
1
2
11.1
3.1

Study Details

Study Description

Brief Summary

This project will apply non-invasive, trans-cutaneous vagal nerve stimulation using various stimulation parameters to young, healthy adults to find the optimal set of parameters to elicit pupil response.

Condition or Disease Intervention/Treatment Phase
  • Device: transcutaneous electrical nerve stimulation devices
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study has a within-subjects design with a randomization of the order of tVNS administered parametersThis study has a within-subjects design with a randomization of the order of tVNS administered parameters
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A: Experimental

Within-subjects design with a randomization of the order of tVNS administered parameters

Device: transcutaneous electrical nerve stimulation devices
electrical stimulation through surface electrodes
Other Names:
  • Digitimer DS7A, Ultima Neo, or InTENSity EX4.
  • Active Comparator: Group B: Active Comparator

    Within-subjects design with a randomization of the order of tVNS administered parameters

    Device: transcutaneous electrical nerve stimulation devices
    electrical stimulation through surface electrodes
    Other Names:
  • Digitimer DS7A, Ultima Neo, or InTENSity EX4.
  • Outcome Measures

    Primary Outcome Measures

    1. Ocular response after transcutaneous nerve stimulation [Visit 1 day]

      Number of participants with pupil response after transcutaneous nerve stimulation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Fluent English speaker with reading and writing proficiency.
    Exclusion Criteria:
    • Participants with significant visual impairment or ocular illness may be excluded at the discretion of the principal investigator.

    • Major medical illnesses including severe neurological illness (e.g. stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)

    • Any history of brain surgery, tumor, intracranial metal implantation, pacemakers, or other implanted devices.

    • Current (i.e. within 48 hours of the session) prescription medication or over-the-counter medication use.

    • Illicit alcohol or drug use. Caffeine (e.g, coffee, energy drinks) consumption prior to the visit.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Eric Porges, PhD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04579653
    Other Study ID Numbers:
    • IRB201903471
    First Posted:
    Oct 8, 2020
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022