Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT07245303
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07245303
Study Brief:
Protocol Section:
NCT07245303