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Recruiting NCT07245303

NCT07245303 Neural Mechanisms of Light Driven Analgesia

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Clinical Trial Summary
NCT ID NCT07245303
Status Recruiting
Phase
Sponsor University of North Carolina, Chapel Hill
Condition Musculoskeletal Pain
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2026-02-24
Primary Completion 2030-01-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
S-cone modulating visual stimulusEqual Energy White Visual StimulusGreen light visual stimulus (S-OFF)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2026-02-24 with a primary completion date of 2030-01-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this study will be to understand the biological mechanisms that are responsible to light-driven analgesia. Light presented to the retina has been shown to have pain relieving properties in pre-clinical and clinical studies. In this study the investigators will evaluate the functional connectivity between subcortical visual areas and non-image forming brain areas that are involved in pain sensation. The investigators will also evaluate how three colored light stimuli presented to the retina results in changes in whole brain evoked activation patterns in participants with chronic musculoskeletal pain and in healthy controls. The investigators will also assess while brain evoked activation patterns in response to a pressure pain stimulus in the presence of three light stimuli in individuals with chronic musculoskeletal pain and healthy controls.

Eligibility Criteria

Inclusion Criteria for participants with cMSP and healthy controls (n=30) * Adults ≥18 years of age. * Individuals who do not have any plans for medication or treatment changes for the next 3 months. * Participants must be willing and able to undergo an MRI. * Participants must not be claustrophobic * Participants must be alert and oriented and able to provide informed consent. * Individuals must be able to speak and read English. Inclusion Criteria for participants with cMSP only (n=30) * To be eligible, participants must have a score of ≥7 on the Widespread pain index (WPI) and ≥5 on the symptom severity scale (SSS), or 4-6 on the WPI and ≥9 on the SSS in the 2016 Fibromyalgia Questionnaire. * Pain symptoms must have been present for 3 months or longer. * Pain must be present in 4 out of 5 body regions. * Individuals enrolled will have an average pain severity ≥4 on the 0-10 NRS over the month prior to enrollment to recruit individuals with moderate to severe chronic MSP. Inclusion Criteria for Participants with Congenital Stationary Night Blindness (n=2) -2 additional participants without chronic MSP will be recruited with diagnosed congenital stationary night blindness Exclusion Criteria: * Presence of retinal vision disorders or conditions resulting in vision impairment. * Patient-reported photosensitivity, photophobia, or aversion (as may occur in autoimmune diseases such as systematic lupus erythematosus). * Disorders including uveitis, cataracts, color-blindness, history of seizure disorder. * Plans for analgesic treatment plan changes in next 3 months (surgery, analgesic medication changes, injections, pain procedures, etc). * Prisoner Status. * Pregnancy. * Contraindications to MRI imaging. These include the presence of implanted/embedded ferromagnetic materials, implanted medical devices that are not MRI compatible, and claustrophobia.

Contact & Investigator

Central Contact

Matthew Mauck, MD, PhD

✉ matt_mauck@med.unc.edu

📞 919-966-5136

Principal Investigator

Matthew Mauck, MD, PhD

PRINCIPAL INVESTIGATOR

University of North Carolina, Chapel Hill

Frequently Asked Questions

Who can join the NCT07245303 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Musculoskeletal Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07245303 currently recruiting?

Yes, NCT07245303 is actively recruiting participants. Contact the research team at matt_mauck@med.unc.edu for enrollment information.

Where is the NCT07245303 trial being conducted?

This trial is being conducted at Chapel Hill, United States.

Who is sponsoring the NCT07245303 clinical trial?

NCT07245303 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Matthew Mauck, MD, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 60 participants.

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