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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DA054845-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Stimulation | Behavioral | AI-guided visual stimuli presented on an electronic screen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 hours |
| Event-related Potential (ERP) | Evoked event-related neural response to contact heat perception measured by EEG (electroencephalography), P300 component | Up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Executive Officer (CEO) | Dandelion Science Corp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dandelion Science | Hoboken | New Jersey | 07030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | Visual Stimulation: AI (Artificial-Intelligence)-guided visual stimuli presented on an electronic screen |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | Visual Stimulation: AI-guided visual stimuli presented on an electronic screen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Sixteen participants removed from analysis due to noisy data | Posted | Mean | Standard Deviation | score on a scale | Up to 2 hours |
|
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Controls | Visual Stimulation: AI-guided visual stimuli presented on an electronic screen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Executive Officer (CEO) | Dandelion Science | 628-777-3477 | info@dandelion.science |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 | Mar 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010775 | Photic Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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|
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| Primary | Event-related Potential (ERP) | Evoked event-related neural response to contact heat perception measured by EEG (electroencephalography), P300 component | Sixteen participants' data removed due to noisy data | Posted | Count of Participants | Participants | Up to 2 hours |
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|
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
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