search
Back to results

Green Light Exposure in Healthy Volunteers Exposure in Normal Human Volunteers

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Green Light Emitting Diode
White Light Emitting Diode
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-50 years healthy men or women
  2. Able to speak and understand English
  3. No history of Chronic pain
  4. No known neuropathies in areas that testing will take place, (forearms, muscle at the base of thumb on the palm of the hand and upper back/shoulder area.

Exclusion Criteria:

  1. Serious mental illness defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality. This will be assessed during the screening interview.
  2. Colorblindness or uncorrected cataracts.
  3. Tissue damage in areas that testing will take place, (forearms, muscle at the base of the thumb on the palm of the hand, and upper back/should area.

Sites / Locations

  • Banner University Medical Center TucsonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Green Light Exposure

White Light Exposure

Arm Description

Subjects will complete thermal and mechanical pain threshold detection tests and Electroencephalography (EEG). After completion, subjects will be exposed to a green light-emitting diode for two hours. After exposure, thermal and mechanical pain threshold assessments and Electroencephalography (EEG) will be conducted.

Subjects will complete thermal and mechanical pain threshold detection tests and Electroencephalography (EEG). After completion, subjects will be exposed to a white light-emitting diode for two hours. After exposure, thermal and mechanical pain threshold assessments and Electroencephalography (EEG) will be conducted.

Outcomes

Primary Outcome Measures

Ascending Pain Pathway
Changes in activity of the ascending pain pathway
Descending Pain Pathway
Changes in activity of the descending pain pathway

Secondary Outcome Measures

Delta Brain Activities
Changes in the baseline of Delta waves of EEG
Theta Brain Activities
Changes in the baseline of Theta waves of EEG
Alpha Brain Activities
Changes in the baseline of Alpha waves of EEG
Sigma Brain Activities
Changes in the baseline of Sigma waves of EEG
Beta Brain Activities
Changes in the baseline of Beta waves of EEG

Full Information

First Posted
February 22, 2022
Last Updated
October 3, 2022
Sponsor
University of Arizona
search

1. Study Identification

Unique Protocol Identification Number
NCT05295225
Brief Title
Green Light Exposure in Healthy Volunteers Exposure in Normal Human Volunteers
Official Title
Investigating the Analgesic Effects of Green Light Exposure in Normal Human Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research project is intended to understand the mechanisms of action for the pain-relieving properties of visual green light exposure. The investigators have shown previously that greenlight exposure decreased acute and chronic pain in both animals and humans. However, the investigators do not yet understand how green light exposure is capable of such function.
Detailed Description
Pain is a biological function. There are several pain centers in the brain that modulate the intensity of the pain signal perceived by the brain. Part of the modulations takes place through two separate pathways. The first pathway mediates pain signals and is known as the ascending facilitator pain pathway. The main function of this pathway is to relay the pain signal to the brain to be processed. The second pathway is known as the descending inhibitory pain pathway. The main function of this pathway is to inhibit the pain signal mediated by the first pathway. Normal humans typically have a balance between the activities of the ascending and descending pain pathways. The investigator animal studies suggest that green light therapy exhibits its pain-relieving effects through altering the balance between the ascending and descending pain pathway in a manner to result in an overall reduction or normalization in pain perception. To test this hypothesis, the investigators propose recruiting 30 healthy human volunteers. The participants will be equally randomized into either green light (treatment) or white light (control) exposure groups. The investigators will initially test the activities of the ascending and descending pathways using thermal and mechanical stimulations. The investigators will also test brain wave activities using a non-invasive EEG device. After establishing the baseline activities of the pain pathways and brain waves, the volunteers will be exposed to the green light or white light at low intensity (4-100 lux) for two hours in our laboratory. After two hours of light exposure, the investigators will again test the activities of the pain pathways using thermal and mechanical stimulation and measure the brain wave EEG activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Green Light Exposure
Arm Type
Active Comparator
Arm Description
Subjects will complete thermal and mechanical pain threshold detection tests and Electroencephalography (EEG). After completion, subjects will be exposed to a green light-emitting diode for two hours. After exposure, thermal and mechanical pain threshold assessments and Electroencephalography (EEG) will be conducted.
Arm Title
White Light Exposure
Arm Type
Placebo Comparator
Arm Description
Subjects will complete thermal and mechanical pain threshold detection tests and Electroencephalography (EEG). After completion, subjects will be exposed to a white light-emitting diode for two hours. After exposure, thermal and mechanical pain threshold assessments and Electroencephalography (EEG) will be conducted.
Intervention Type
Device
Intervention Name(s)
Green Light Emitting Diode
Other Intervention Name(s)
GLED
Intervention Description
GLED exposure for two hours
Intervention Type
Device
Intervention Name(s)
White Light Emitting Diode
Other Intervention Name(s)
WLED
Intervention Description
WLED exposure for two hours
Primary Outcome Measure Information:
Title
Ascending Pain Pathway
Description
Changes in activity of the ascending pain pathway
Time Frame
Two hours
Title
Descending Pain Pathway
Description
Changes in activity of the descending pain pathway
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Delta Brain Activities
Description
Changes in the baseline of Delta waves of EEG
Time Frame
Two hours
Title
Theta Brain Activities
Description
Changes in the baseline of Theta waves of EEG
Time Frame
Two hours
Title
Alpha Brain Activities
Description
Changes in the baseline of Alpha waves of EEG
Time Frame
Two hours
Title
Sigma Brain Activities
Description
Changes in the baseline of Sigma waves of EEG
Time Frame
Two hours
Title
Beta Brain Activities
Description
Changes in the baseline of Beta waves of EEG
Time Frame
Two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-50 years healthy men or women Able to speak and understand English No history of Chronic pain No known neuropathies in areas that testing will take place, (forearms, muscle at the base of thumb on the palm of the hand and upper back/shoulder area. Exclusion Criteria: Serious mental illness defined as distortions of perception, delusions, hallucinations, and unusual behaviors resulting in loss of contact with reality. This will be assessed during the screening interview. Colorblindness or uncorrected cataracts. Tissue damage in areas that testing will take place, (forearms, muscle at the base of the thumb on the palm of the hand, and upper back/should area.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent F Martin, PhD
Phone
(312) 909-2655
Email
laurentmartin@arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohab Ibrahim, PhD., MD.
Phone
(520) 874-7246
Email
mibrahim@anesth.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohab Ibrahim, PhD, MD.
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohab M Ibrahim, Phd., MD.
Phone
520-874-7246
Email
mibrahim@anesth.arizona.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28092651
Citation
Ibrahim MM, Patwardhan A, Gilbraith KB, Moutal A, Yang X, Chew LA, Largent-Milnes T, Malan TP, Vanderah TW, Porreca F, Khanna R. Long-lasting antinociceptive effects of green light in acute and chronic pain in rats. Pain. 2017 Feb;158(2):347-360. doi: 10.1097/j.pain.0000000000000767.
Results Reference
result

Learn more about this trial

Green Light Exposure in Healthy Volunteers Exposure in Normal Human Volunteers

We'll reach out to this number within 24 hrs