Migraine Disorders, Photophobia
Conditions
Keywords
migraine, photophobia, light sensitivity, melanopsin cells, intrinsically photosensitive retinal ganglion cells
Brief summary
The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.
Interventions
DEVICEInvestigational Coating
Sponsors
Primary Children's Hospital
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Must be diagnosed with migraine with aura or migraine without aura 2. Must have at least 10 headache days per month
Exclusion criteria
1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity 2. Pregnant 3. Unwilling or unable in the judgment of the investigator to complete the study 4. Unavailable for any of the study visits 5. Light sensitive conditions: meningitis, iritis, blepharospasm, albinism 6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy 7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs 8. Best corrected visual acuity less than 20/40 in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIT-6 Score | 12 weeks | The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Coating Investigational Coating | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 27 |
Baseline characteristics
| Characteristic | Investigational Coating |
|---|---|
| Age, Categorical <=18 years | 35 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 13 years STANDARD_DEVIATION 3.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
HIT-6 Score
The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.
Time frame: 12 weeks
Population: Only subjects that completed the trial were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Coating | HIT-6 Score | 62.3 units on a scale | Standard Deviation 4.8 |