Visual ImpairmentPuLCANCT04579653
Pupillometry and Locus Coeruleus Activation (PuLCA)
A study testing transcutaneous electrical nerve stimulation devices in people with Visual Impairment and Ocular Illness, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Ocular Illness
- What is being tested?
- transcutaneous electrical nerve stimulation devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2023to 24 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent English speaker with reading and writing proficiency.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation
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.
- Conditions
- Visual Impairment, Ocular Illness
- Being tested
- transcutaneous electrical nerve stimulation devices
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulation devicesDevice
Also called Digitimer DS7A, Ultima Neo, or InTENSity EX4.
electrical stimulation through surface electrodes
| Study group | Role | What they receive |
|---|---|---|
| Group A: Experimental | Experimental | Within-subjects design with a randomization of the order of tVNS administered parameters Receives: Device: transcutaneous electrical nerve stimulation devices |
| Group B: Active Comparator | Active comparator | Within-subjects design with a randomization of the order of tVNS administered parameters Receives: Device: transcutaneous electrical nerve stimulation devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular response after transcutaneous nerve stimulation
Number of participants with pupil response after transcutaneous nerve stimulation
Measured: Visit 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start22 Nov 2023 (estimated)
- Primary completion23 Nov 2023 (estimated)
- Study completion24 Nov 2023 (estimated)
Why it stopped: Staff who where to run the study left.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study has a within-subjects design with a randomization of the order of tVNS administered parameters
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Porges, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579653
- Sponsor's protocol ID
- IRB201903471
- Acronym
- PuLCA
- Status last verified
- Dec 2023
- First submitted
- 5 Aug 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation
- ClinicalTrials.gov ID
- NCT04579653
- Acronym / sponsor ID
- PuLCA / IRB201903471
- Conditions
- Visual Impairment, Ocular Illness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Staff who where to run the study left.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 Nov 2023 (estimated)
- Primary completion
- 23 Nov 2023 (estimated)
- Study completion
- 24 Nov 2023 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study has a within-subjects design with a randomization of the order of tVNS administered parameters
| Arm | Type | Receives |
|---|---|---|
| Group A: Experimental | Experimental | Device: transcutaneous electrical nerve stimulation devicesWithin-subjects design with a randomization of the order of tVNS administered parameters |
| Group B: Active Comparator | Active comparator | Device: transcutaneous electrical nerve stimulation devicesWithin-subjects design with a randomization of the order of tVNS administered parameters |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Fluent English speaker with reading and writing proficiency.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical nerve stimulation devicesAlso: Digitimer DS7A, Ultima Neo, or InTENSity EX4.electrical stimulation through surface electrodes | Device | Group A: Experimental, Group B: Active Comparator |
Primary outcome
Ocular response after transcutaneous nerve stimulation
Time frame: Visit 1 day
Number of participants with pupil response after transcutaneous nerve stimulation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
Related trials for Visual Impairment
Not yet recruiting
joyVision: The Superiority of Co-design in the Development of a Serious Game for Children With Cerebral Visual Impairment
Cerebral Visual Impairment
RecruitingPhase 3
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Radiation Retinopathy, Visual Impairment
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Recruiting
Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired Adults
Visual Impairments, Low Vision Digital Assistance
Active, not recruiting
Evaluation on Visual Outcome of TMS
Visual Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Porges, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation devices in people with Visual Impairment and Ocular Illness, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular response after transcutaneous nerve stimulation (time frame: Visit 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023; AzTrials last refreshed its copy on 28 Oct 2026.