Visual Stimulation for Pain Relief

NCT06276881 | Completed Results

• 2 other identifiers: DSC10011R43DA054845-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Healthy Controls

EXPERIMENTAL

Behavioral: Visual Stimulation

Interventions

Visual Stimulation BEHAVIORAL

AI-guided visual stimuli presented on an electronic screen

Healthy Controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• to 50 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Dandelion Science: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Dandelion Science

Hoboken, New Jersey, 07030, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Photic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Results Point of Contact

• Title: Chief Executive Officer (CEO)
• Organization: Dandelion Science

info@dandelion.science

628-777-3477

Study Officials

• Chief Executive Officer (CEO)

  Dandelion Science Corp

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 26, 2024
• Study Start: June 3, 2022
• Primary Completion: December 28, 2022
• Study Completion: May 1, 2023
• Last Updated: August 7, 2024
• Results First Posted: April 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)