Trial Outcomes & Findings for Visual Stimulation for Pain Relief (NCT NCT06276881)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

Up to 2 hours

Results posted on

2024-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Controls Visual Stimulation: AI (Artificial-Intelligence)-guided visual stimuli presented on an electronic screen
Overall Study STARTED	75
Overall Study Generating and Validating the Stimuli	10
Overall Study Testing Medoc, Validating Thermal Responses	18
Overall Study Testing Pain Relief (Analysis Group)	47
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls n=75 Participants Visual Stimulation: AI-guided visual stimuli presented on an electronic screen
Age, Continuous	24.97 years STANDARD_DEVIATION 5.83 • n=75 Participants
Sex: Female, Male Female	41 Participants n=75 Participants
Sex: Female, Male Male	34 Participants n=75 Participants
Region of Enrollment United States	75 Participants n=75 Participants

PRIMARY outcome

Timeframe: Up to 2 hours

Population: Sixteen participants removed from analysis due to noisy data

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.

Outcome measures

Outcome measures
Measure	Healthy Controls n=31 Participants Visual Stimulation: AI-guided visual stimuli presented on an electronic screen
Visual Analog Scale (VAS) Score VAS Score in Response to No Visual Stimulation	24.77 score on a scale Standard Deviation 20.51
Visual Analog Scale (VAS) Score VAS Score in Response to Flicker Visual Stimulation	25.02 score on a scale Standard Deviation 21.55
Visual Analog Scale (VAS) Score VAS Score in Response to Abstract Visual Stimulation	25.19 score on a scale Standard Deviation 21.13
Visual Analog Scale (VAS) Score VAS Score in Response to Semantic Visual Stimulation	23.64 score on a scale Standard Deviation 21.19

PRIMARY outcome

Timeframe: Up to 2 hours

Population: Sixteen participants' data removed due to noisy data

Evoked event-related neural response to contact heat perception measured by EEG (electroencephalography), P300 component

Outcome measures

Outcome measures
Measure	Healthy Controls n=31 Participants Visual Stimulation: AI-guided visual stimuli presented on an electronic screen
Event-related Potential (ERP)	31 Participants

Adverse Events

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Executive Officer (CEO)

Dandelion Science

Phone: 628-777-3477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place