Healthy Participants
Conditions
Brief summary
This a single site, observational study that will examine how the pupil responds to neurostimulation under different conditions in healthy adults. The objective is to measure pupillary dilation reflex (PRD) in response to increasing neurostimulation intensities using the AlgometRx device.
Interventions
OTHERNo intervention (observational study)
No intervention
Sponsors
Children's National Research Institute
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-60 years. * In good general health (self-reported). * Able and willing to provide written informed consent.
Exclusion criteria
* Eye pathology that prevents accurate pupillometry. * Pregnancy (Self-Report) * Diagnosis of autoimmune disorders. * Diagnosis of any neuropathic disorder * Inability to complete questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pupillary Dilation Amplitude in Response to Increasing Neurostimulation Intensity Measured by AlgometRx Infrared Pupillometer | Day 1 | Pupillary dilation amplitude is defined as the maximum increase in pupil diameter from the pre-stimulus baseline, measured in millimeters (mm) using the AlgometRx infrared pupillometer. Pupil diameter is recorded before, during, and for 10 seconds following each 1-second stimulus. Amplitude is assessed at each stimulation intensity, beginning at 1.0 mA and increasing in 1 mA steps until participant perception, followed by measurements at 2 mA and 4 mA above the perception threshold, at each of three frequencies (5 Hz, 250 Hz, and 2000 Hz). Reported as the mean pupillary dilation amplitude in millimeters at each intensity and frequency combination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Pupil Diameter Variability During the Pre-Stimulation Period Measured by AlgometRx Infrared Pupillometer | Day 1 | Variability of pupil diameter recorded by the AlgometRx infrared pupillometer during the pre-stimulation baseline period, while participants fixate on a visual marker in a quiet room under controlled lighting for up to 5 minutes. Variability is calculated as the standard deviation of pupil diameter, in millimeters (mm), across the final 30 seconds of the baseline recording. Reported as the mean standard deviation in millimeters. |
| Area Under the Pupillary Dilation Curve (AUC) Measured by AlgometRx Infrared Pupillometer | Day 1 | Area under the curve (AUC) is calculated from the pupil diameter-time curve recorded over the 10-second period following each 1-second stimulus, using the AlgometRx infrared pupillometer, and is expressed in millimeter-seconds (mm\*s). AUC is assessed at each stimulation intensity, beginning at 1.0 mA and increasing in 1 mA steps until participant perception, followed by measurements at 2 mA and 4 mA above the perception threshold, at each of three frequencies (5 Hz, 250 Hz, and 2000 Hz). Reported as the mean AUC in millimeter-seconds at each intensity and frequency combination. |
| Difference in Pupillary Dilation Amplitude Between Ambient Lighting Conditions Measured by AlgometRx Infrared Pupillometer | Day 1 | Within-participant difference in pupillary dilation amplitude, measured in millimeters (mm) by the AlgometRx infrared pupillometer, between testing under approximately 100 lux and approximately 400 lux ambient lighting. Amplitude is defined as the maximum increase in pupil diameter from the pre-stimulus baseline. Reported as the mean within-participant difference in millimeters. |
| Inter-Ocular Agreement in Pupillary Dilation Amplitude Measured by AlgometRx Binocular Handheld Attachment | Day 1 | Agreement between left-eye and right-eye pupillary dilation amplitude recorded simultaneously using the AlgometRx binocular handheld attachment under identical stimulation and lighting conditions. Amplitude is defined as the maximum increase in pupil diameter from the pre-stimulus baseline, measured in millimeters. Agreement is expressed as an intraclass correlation coefficient (ICC) ranging from 0 to 1, where higher values indicate greater agreement between eyes. Reported as the ICC with a 95% confidence interval. |
| Percentage of Participants With Successful Simultaneous Binocular Pupillary Recording Using the AlgometRx Binocular Handheld Attachment | Day 1 | The percentage of participants in whom the AlgometRx binocular handheld attachment successfully captures interpretable simultaneous pupillary recordings from both eyes. A recording is considered successful if both pupils are tracked continuously throughout the stimulus and post-stimulus recording period. Reported as the percentage of participants with successful binocular recording. |
Countries
United States
Outcome results
None listed