Visual Stimulation for Pain Relief

Pain Relief Through Artificial Intelligence (AI) -Guided Dynamic Neuromodulation

The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Visual Stimulation

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hoboken, New Jersey, United States, 07030
      • Dandelion Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Controls	Behavioral: Visual Stimulation; AI-guided visual stimuli presented on an electronic screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dandelion Science
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Chief Executive Officer (CEO), Dandelion Science Corp

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2022
• Primary Completion (Actual): December 28, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DSC1001; 1R43DA054845-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No