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Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity

Study Purpose

Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adults greater than or equal to 18.
  • - Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician.
  • - Individuals who experience an average pain severity greater than 7/10 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.

Exclusion Criteria:

  • - Vision disorders or conditions resulting in severe vision impairment or blindness.
  • - Individuals with self-report of color blindness.
  • - Alert and oriented, and able to provide informed consent.
  • - Ability to read and speak English to complete validated questionnaires.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05956067
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of North Carolina, Chapel Hill
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Matthew C Mauck, MD, PhD
Principal Investigator Affiliation University of North Carolina, Chapel Hill
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Chronic Low-back Pain, Chronic Pain, Fibromyalgia
Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Experimental: 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.

Interventions

Other: - Green Light stimulation

A portable battery-operated ganzfeld light stimulation device will be used to deliver green light for 2 hours per day for 5 consecutive days.

Other: - Equal Energy White stimulation

A portable battery-operated ganzfeld light stimulation device will be used to deliver white light for 2 hours per day for 5 consecutive days.

Other: - S-cone modulating white light

A portable battery-operated ganzfeld light stimulation device will be used to deliver S-cone modulating light for 2 hours per day for 5 consecutive days.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University Of North Carolina, Chapel Hill, North Carolina

Status

Address

University Of North Carolina

Chapel Hill, North Carolina, 27517

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