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

Phase 2

• Conditions: Migraine Headache
• Interventions: Device: Argus Migraine Treatment device

• Registration Number: NCT02969642
• Lead Sponsor: The San Francisco Clinical Research Center

Brief 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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02
• Primary Completion: 2017-05
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Argus Migraine Treatment device	Sham low energy laser using approximately 1/1000 th energy of treatment laser.
Treatment	Argus Migraine Treatment device	Treatment laser.

Primary Outcome Measures

Name	Time	Method
Differences between treatment groups in pain free rates at 2 hours post treatment.	2 hours post treatment

Trial Locations

Locations (1)

San Francisco Clinical Research Center; 🇺🇸 San Francisco, California, United States