Pain
Conditions
Brief summary
The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.
Interventions
BEHAVIORALVisual Stimulation
AI-guided visual stimuli presented on an electronic screen
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Dandelion Science
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants of both sexes * Participants of diverse ethnic and racial backgrounds * Participants who speak, read, and understand English and are willing and able to provide written informed * 18 to 50 years old
Exclusion criteria
* Participants with neurologic, endocrine, renal, gastrointestinal, and chronic pain disease * Participants who use unprescribed drugs or medications * Chronically medicated participants * Participants with photosensitivity and epileptic seizures * Participants who have undergone major surgery within two months of the experiment date * Participants with cardiac disorders * Participants who are pregnant * Prisoners * Participants who are unable to provide consent * Participants diagnosed with a psychiatric disorder that is likely to interfere with the conduct of the study * Participants with implanted electronic devices of any kind, including pace-makers, electronic infusion pumps, stimulators, defibrillators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Score | Up to 2 hours | Standard computerized scale of perceived pain level. The scale ranges from 0 to 100, a score of 0 indicating No Pain and a score of 100 indicating Most Pain. Higher score indicates a worse outcome as perceived pain is increasing, lower score indicates a better outcome as perceived pain is decreasing. |
| Event-related Potential (ERP) | Up to 2 hours | Evoked event-related neural response to contact heat perception measured by EEG (electroencephalography), P300 component |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Controls Visual Stimulation: AI-guided visual stimuli presented on an electronic screen | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Healthy Controls | — |
|---|---|---|
| Age, Continuous | 24.97 years STANDARD_DEVIATION 5.83 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 75 Participants | — |
| Sex: Female, Male Female | 41 Participants | — |
| Sex: Female, Male Male | 34 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
Primary
Event-related Potential (ERP)
Evoked event-related neural response to contact heat perception measured by EEG (electroencephalography), P300 component
Time frame: Up to 2 hours
Population: Sixteen participants' data removed due to noisy data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Controls | Event-related Potential (ERP) | 31 Participants |
p-value: 0.07ANOVA
Primary
Visual Analog Scale (VAS) Score
Standard computerized scale of perceived pain level. The scale ranges from 0 to 100, a score of 0 indicating No Pain and a score of 100 indicating Most Pain. Higher score indicates a worse outcome as perceived pain is increasing, lower score indicates a better outcome as perceived pain is decreasing.
Time frame: Up to 2 hours
Population: Sixteen participants removed from analysis due to noisy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Visual Analog Scale (VAS) Score | VAS Score in Response to No Visual Stimulation | 24.77 score on a scale | Standard Deviation 20.51 |
| Healthy Controls | Visual Analog Scale (VAS) Score | VAS Score in Response to Flicker Visual Stimulation | 25.02 score on a scale | Standard Deviation 21.55 |
| Healthy Controls | Visual Analog Scale (VAS) Score | VAS Score in Response to Abstract Visual Stimulation | 25.19 score on a scale | Standard Deviation 21.13 |
| Healthy Controls | Visual Analog Scale (VAS) Score | VAS Score in Response to Semantic Visual Stimulation | 23.64 score on a scale | Standard Deviation 21.19 |
p-value: 0.37t-test, 1 sided