Migraine Headache Mitigation Utilizing Avulux

Migraine Clinical Trial

Official title:

Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06149000
• Other study ID #: Avulux
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: November 2023
• Source: Kaiser Permanente
• Contact: Leslie Aragon, MPH
• Phone: 323-812-5569
• Email: Leslie.A.Aragon[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients

Description:

Participants:

This study will include a total of 40 participants aged 18 and over who have been screened for migraine headache history. Patients who attended the SBC Headache class with a diagnosis of Migraine from the last 12 months will be selected and assigned a number. Random number set will be used to select the 40 patients. Additional 40 patients will be selected to meet the total initial enrollment of 40 patients in the end. These 40 patients will be randomly assigned to Avulux or Control groups. Each patient will be assigned a unique identifier, and the rest of the correspondents will not use patient demographics.

Design:

The study will be a randomized, double blind, crossover interventional trial. Participants will be randomly assigned to one of 2 groups of 20. 1. Experimental Group: Participants in this group will wear Avulux lenses during the testing sessions. 2. Control Group: Participants in this group will wear placebo lenses that resemble Avulux lenses but do not have the same optical properties.

Procedure:

Participants will complete a baseline assessment and self-report migraine frequency using the Redcap migraine diary application. Participants will complete testing sessions with both Avulux and placebo lenses for the duration of 3 months and then switch lenses for the remaining 3 months for comparison and a total study period of 6 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 20, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Patient population: Individuals must have an existing diagnosis code of G43.1 (migraine w aura) or G43. 10 (migraine w aura, not intractable).

• Only Kaiser Permanente members receiving care at the Fontana Medical Service Areas will be in consideration.

• Patients that are >18

• There will no restrictions based on biological sex.

• Participants will be referred to optical by provider (Neurologists/Optometrist/Primary Care physician).

• Participants must agree to not initiate any new medical management during the trial or be willing to voluntarily withdrawal from participating in the trial

Exclusion Criteria:

• Patients who do not have a migraine diagnosis code in their medical record.

• Patients that have started a new migraine medication within last 30 days

• Non-Members of Kaiser Permanente

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Photophobia

Intervention

Device:
• Avulux Lenses
Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines
• Placebo Lenses
Lenses that will look identical to Avulux lenses without the medical benefits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

References & Publications (4)

Huang J, Zong X, Wilkins A, Jenkins B, Bozoki A, Cao Y. fMRI evidence that precision ophthalmic tints reduce cortical hyperactivation in migraine. Cephalalgia. 2011 Jun;31(8):925-36. doi: 10.1177/0333102411409076. Epub 2011 May 26. — View Citation

Katz BJ, Digre KB. Diagnosis, pathophysiology, and treatment of photophobia. Surv Ophthalmol. 2016 Jul-Aug;61(4):466-77. doi: 10.1016/j.survophthal.2016.02.001. Epub 2016 Feb 12. — View Citation

Posternack C, Kupchak P, Capriolo AI, Katz BJ. Targeting the intrinsically photosensitive retinal ganglion cell to reduce headache pain and light sensitivity in migraine: A randomized double-blind trial. J Clin Neurosci. 2023 Jul;113:22-31. doi: 10.1016/j.jocn.2023.04.015. Epub 2023 May 5. — View Citation

Wilkins AJ, Wilkinson P. A tint to reduce eye-strain from fluorescent lighting? Preliminary observations. Ophthalmic Physiol Opt. 1991 Apr;11(2):172-5. doi: 10.1111/j.1475-1313.1991.tb00217.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in migraine frequency	headache days per month documented in a headache diary.	6 months
Primary	Reduction in migraine severity	Severity of headaches on a scale from no, mild, moderate, and sever pain	6 months
Secondary	Improve quality of life	Rating of daily activity performance using Functional Disability Scale (0) No disability-(6) Severe disability	6 months
Secondary	Medication Use	Number of medications used as a form of rescue medication during episode of migraine	6 months

External Links

•   Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical Neuroscience
•   Avulux Randomized Trial