Neural Mechanisms of Light Driven Analgesia
Recruiting · NCT07245303 · Interventional (participants receive a specific treatment) · Lead sponsor: University of North Carolina, Chapel Hill
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
- 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.
Where it is running
1 location listed across 1 US state.
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States