Migraine Headache Clinical Trial
Official title:
A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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