Study of Low-level Laser Therapy in the Acute Treatment of Migraine

Study Overview
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Brief Summary
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This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).

Detailed Description
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This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The sham laser emits approximately 1/1000 the energy of the treatment laser. It is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the SPG following laser stimulation. Subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment. Subjects will be further contacted 24 hours and one month post treatment. Adverse events will be monitored and recorded.

Official Title
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A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine

Conditions
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Migraine Headache

Intervention / Treatment
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* Device: Argus Migraine Treatment device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria male or female aged 18 or older; subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3; 1-20 headache days per month; history of at least moderate pain if migraine left untreated. Exclusion Criteria: headache on greater than 25 days/month on average for preceding 3 months; headache on greater than 25 days in present month; headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc; women of child bearing age not using acceptable method of contraception; pregnant or nursing women; history of malignancy of any organ uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse; light sensitivity; retinal disease; intranasal pathology.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>Sham low energy laser using approximately 1/1000 th energy of treatment laser. | Device: Argus Migraine Treatment device<br>* treatment of Migraines targeting Sphenopalatine ganglion<br>* Other names: low energy laser therapy;|
| Active Comparator: Treatment<br>Treatment laser. | Device: Argus Migraine Treatment device<br>* treatment of Migraines targeting Sphenopalatine ganglion<br>* Other names: low energy laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between treatment groups in pain free rates at 2 hours post treatment. |  | 2 hours post treatment |