Back to resultsPupillometry and Locus Coeruleus Activation (PuLCA) (PuLCA)
Primary Purpose
Visual Impairment, Ocular Illness
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcutaneous electrical nerve stimulation devices
Sponsored by
About this trial
This is an interventional basic science trial for Visual Impairment
Eligibility Criteria
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.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A: Experimental
Group B: Active Comparator
Arm Description
Within-subjects design with a randomization of the order of tVNS administered parameters
Within-subjects design with a randomization of the order of tVNS administered parameters
Outcomes
Primary Outcome Measures
Ocular response after transcutaneous nerve stimulation
Number of participants with pupil response after transcutaneous nerve stimulation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04579653
Brief Title
Pupillometry and Locus Coeruleus Activation (PuLCA)
Acronym
PuLCA
Official Title
Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment, Ocular Illness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study has a within-subjects design with a randomization of the order of tVNS administered parameters
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Experimental
Arm Type
Experimental
Arm Description
Within-subjects design with a randomization of the order of tVNS administered parameters
Arm Title
Group B: Active Comparator
Arm Type
Active Comparator
Arm Description
Within-subjects design with a randomization of the order of tVNS administered parameters
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical nerve stimulation devices
Other Intervention Name(s)
Digitimer DS7A, Ultima Neo, or InTENSity EX4.
Intervention Description
electrical stimulation through surface electrodes
Primary Outcome Measure Information:
Title
Ocular response after transcutaneous nerve stimulation
Description
Number of participants with pupil response after transcutaneous nerve stimulation
Time Frame
Visit 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Porges, PhD
Phone
3522945838
Email
eporges@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Porges, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
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Pupillometry and Locus Coeruleus Activation (PuLCA)
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