NCT02969642

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The San Francisco Clinical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DEVICE	Argus Migraine Treatment device	treatment of Migraines targeting Sphenopalatine ganglion

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-05-01
• Completion: 2017-07-01
• First posted: 2016-11-21
• Last updated: 2016-12-02

Locations

1 site across 1 country: United States