Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
NCT ID: NCT05956067
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
60 participants
INTERVENTIONAL
2023-08-25
2026-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Equal energy white stimulus
Equal energy white light at 500 lux. The International Commission on Illumination (CIE) coordinates of this light are (x=y=0.33), indicating that the stimulus appears uniformly white which means that the activation of each of the three classes of photoreceptors are equivalent, thus silencing any chromatic opponency. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.
Equal Energy White stimulation
A portable battery-operated ganzfeld light display will be used to deliver white light for 2 hours per day for 5 consecutive days.
Green light stimulus
Green light at 500 lux. Participants will view 545 nm green light delivered via a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.
Green Light stimulation
A portable battery-operated ganzfeld light display will be used to deliver green light for 2 hours per day for 5 consecutive days.
S-cone modulating white light
The S-cone modulating light stimulus will alternate between two light conditions at 500 lux that will activate the S-cones by about 100x differentially between the two conditions while maintaining the L- an M-cones at constant activation between the two alternating conditions using 427 nm versus 545 nm light. The stimulus will be delivered by a portable battery-operated ganzfeld light stimulation device for 2 hours per day for 5 consecutive days.
S-cone modulating white light
A portable battery-operated ganzfeld light display will be used to deliver S-cone modulating light for 2 hours per day for 5 consecutive days.
Interventions
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Green Light stimulation
A portable battery-operated ganzfeld light display will be used to deliver green light for 2 hours per day for 5 consecutive days.
Equal Energy White stimulation
A portable battery-operated ganzfeld light display will be used to deliver white light for 2 hours per day for 5 consecutive days.
S-cone modulating white light
A portable battery-operated ganzfeld light display will be used to deliver S-cone modulating light for 2 hours per day for 5 consecutive days.
Eligibility Criteria
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Inclusion Criteria
* Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician.
* Individuals who experience an average pain severity greater than 4/10 in intensity at baseline.
* Willingness to wear a battery-operated portable ganzfeld light stimulator device for 2 hours per day at the same time each day (ideally complete the light therapy session between 5 am-10 am each morning) for 5 days.
* Alert and oriented, and able to provide informed consent
* Ability to read and speak English to complete validated questionnaires.
Exclusion Criteria
* Individuals with self-report of color blindness
* Prisoner Status
* Pregnancy
* No other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger the patient).
* History of seizure disorder
18 Years
65 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Matthew C Mauck, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University Of North Carolina
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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23-1301
Identifier Type: -
Identifier Source: org_study_id
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