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NCT06276881 Clinical Trial

Visual Stimulation for Pain Relief

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06276881
Other study ID # DSC1001
Secondary ID 1R43DA054845-01
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2022
Est. completion date May 1, 2023

Study information
Verified date March 2024
Source Dandelion Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date May 1, 2023
Est. primary completion date December 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Visual Stimulation
AI-guided visual stimuli presented on an electronic screen

Locations
Country Name City State
United States Dandelion Science Hoboken New Jersey

Sponsors (3)
Lead Sponsor Collaborator
Dandelion Science National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. Up to 2 hours
Primary 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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